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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12614000289617
Ethics application status
Approved
Date submitted
7/03/2014
Date registered
19/03/2014
Date last updated
2/11/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
A single centre nested cohort study investigating the safety and efficacy of using 0.9 % saline or Plasma-Lyte(Registered Trademark) 148 as post-operative fluid therapy in adults undergoing cardiac surgery
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Scientific title
A single centre nested cohort study investigating the safety and efficacy of using 0.9 % saline or Plasma-Lyte "(Registered Trademark)" as post-operative fluid therapy in adults undergoing cardiac surgery
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Secondary ID [1]
284218
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Nil
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Universal Trial Number (UTN)
U1111-1152-2216
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery
291328
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Condition category
Condition code
Surgery
291684
291684
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0
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Other surgery
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Cardiovascular
291720
291720
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study is conducted as a single centre nested cohort study within the SPLIT study (0.9 % Saline versus Plasma-Lyte 148 for Intensive Care Fluid Therapy).
Patients enrolled into the SPLIT study, following cardiac surgery .During the study period the intensive care unit will be randomly assigned to a 7 week period of administration of trial fluid. There is a double crossover approach so that the each strategy is given twice.
Plasma-lyte 148 for intravenous fluid therapy in intensive care. The rate, duration, and frequency of fluid administration will determined by the treated clinician. All fluid used for either fluid resuscitation or crystalloid rehydration will be Plasma-Lyte 148 unless a specific indication exists for another fluid.
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Intervention code [1]
288919
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Treatment: Other
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Comparator / control treatment
During the study period patients will receive 0.9% saline (control arm) the rate, duration, and frequency of fluid administration will determined by the treated clinician.
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Control group
Active
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Outcomes
Primary outcome [1]
291627
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Chest tube output at from time of arrival to Intensive care Unit til 12 hours post operatively. - Outcome will be recorded as the volume in chest tube at 12 hours
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Assessment method [1]
291627
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Timepoint [1]
291627
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12 hours after arrival to ICU
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Secondary outcome [1]
307187
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Volume of fluid in chest drains at 24 hours - Outcome will be recorded as the volume in chest tube at 24 hours
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Assessment method [1]
307187
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Timepoint [1]
307187
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24 hours after arrival to ICU, if still in ICU
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Secondary outcome [2]
307188
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Total volume of fluid in chest drains at time of ICU discharge - Outcome will be recorded as the volume in chest tube at time of ICU discharge
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Assessment method [2]
307188
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Timepoint [2]
307188
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Assessed at time of ICU discharge or when chest tube is taken out
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Secondary outcome [3]
307189
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Proportion of patients requring a return to theatre for bleeding
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Assessment method [3]
307189
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Timepoint [3]
307189
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Monitored daily throughout duration of hospital stay of each participant
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Secondary outcome [4]
307190
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Proportions of patients requiring blood products, type of blood product, and volume administered - As recorded on patient clinical records
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Assessment method [4]
307190
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Timepoint [4]
307190
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Monitored daily throughout duration of ICU stay of each participant
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Secondary outcome [5]
307191
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Total amount of study fluid given - As recorded on patient clinical records
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Assessment method [5]
307191
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Timepoint [5]
307191
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Monitored daily throughout duration of ICU stay of each participant
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Secondary outcome [6]
307192
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Daily Haemoglobin level. The haemoglobin values used will be serum heamoglobin measures taken for clinical purposes
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Assessment method [6]
307192
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Timepoint [6]
307192
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Monitored daily throughout duration of ICU stay of each participant
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Secondary outcome [7]
307193
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Duration of mechanical ventilation - As recorded on patient clinical records
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Assessment method [7]
307193
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Timepoint [7]
307193
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Monitored daily throughout duration of ICU stay of each participant
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Secondary outcome [8]
307194
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Time until free from inotropes - As recorded on patient clinical records
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Assessment method [8]
307194
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Timepoint [8]
307194
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Monitored daily throughout duration of ICU stay of each participant
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Secondary outcome [9]
307195
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Daily fluid balance - As recorded on patient clinical records
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Assessment method [9]
307195
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Timepoint [9]
307195
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Monitored daily throughout duration of ICU stay of each participant
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Secondary outcome [10]
307196
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Difference between pre-operative weight and ICU discharge weight
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Assessment method [10]
307196
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Timepoint [10]
307196
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Weight at time of ICU discharge
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Secondary outcome [11]
307197
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Composite outcome of major postoperative complication - Death during hospital admisision - Myocardial infraction - Renal failure (requring dialysis) - Cerebrovascular event As recorded on medical discharge summary
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Assessment method [11]
307197
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Timepoint [11]
307197
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Assessed at discharge from hospital
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Secondary outcome [12]
307198
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ICU re-admisison Recorded as a review of patient records
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Assessment method [12]
307198
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Timepoint [12]
307198
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At discharge from hospital
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Secondary outcome [13]
307199
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ICU length of stay
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Assessment method [13]
307199
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Timepoint [13]
307199
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At discharge from ICU
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Eligibility
Key inclusion criteria
Adult patients > 18 years
Elective or emergency cardiac surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who are <18 years in age
Patients who are expected to require renal replacement therapy within six hours of ICU admission
Patients who are usually on dialysis for end stage renal failure
Patients who are admitted to the ICU solely for consideration of organ donation or for palliative care
Patients previously enrolled in the SPLIT trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The ICU at Wellington Regional Hospital will be randomly assigned, in alternating seven week blocks, to use blinded 0.9% saline or Plasma- Lyte "(Registered Trademark) 148 as the default fluid.
Any patient who remains in the ICU after a crossover period will continue to receive the study fluid to which they were originally assigned up to 90 days after enrolment. As a result, no washout is required between crossover
periods.
The treatments will be administered ‘blind’ to both
investigators and patients. We will use a double crossover approach so each treatment strategy is used twice. Any patients readmitted to the ICU within the index hospital admission will continue to receive the fluid they were originally assigned to even if the unit-wide crossover has
occurred. If patients are readmitted to the ICU beyond their index hospital admission, they will not be required to receive study fluid.
The allocation of study treatments in will be determined ahead of time by the study statistician. Masked study fluid appropriate for each study block which is labelled either 'fluid A' or 'fluid B' will be delivered to each study unit by Baxter Pty Ltd (who will prepare blinded study fluids for this study). Allocation concealment will be maintained until all analyses (including post hoc analyses) are complete.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of study treatments will be determined at random by the study statistician using a computer algorithm.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
This study utilises a novel design in order to assess the relative efficacy of two standard treatment approaches. Although this study is clearly an interventional study on the basis of the Guidelines, it has many features that are more akin to an observational study than an interventional one.
Specifically, the study involves no departure from standard care and does not involve the collection of any data that are not already being collected for clinical and / or quality assurance purposes. In this study, whether or not ICU patients receive 0.9% saline or Plasma-Lyte (Registered Trademark) 148 as default therapy will be determined, on the basis of whether they are cared for in ICU.
All patients in this study will receive standard treatment except that the default therapy they receive will be randomly allocated according to the 7 week block with a double crossover .
Attending ICU specialists will have full discretion to use whichever study fluid they choose if a specific indication for one fluid or the other arises. As a result of these factors, this study involves negligible risk
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Phase
Phase 4
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Type of endpoint/s
Safety
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Statistical methods / analysis
Currently there is a lack of established statistical methodologies for calculating sample size for cluster cross over trials with binary outcome variables. The data obtained in this study will be used to facilitate modelling of sample size requirements for a larger scale study.
There have been no studies done in this population to be able to predict an anticipated effect size of the IV fluid intervention. However, from a yet to be published pilot study of 50 patients undergoing cardiac surgery at Wellington Regional Hospital there was an estimated chest tube drainage at 24 hours or until time of ICU discharge of 706.08 mL, Standard deviation = 462.648 mL. A total sample size of 246 patient has 80% power to detect differences with a magnitude expressed as effect size of 0.36 using bilateral tests and significance level 0.05.
A complete description of the statistical analyses will be specified in a statistical analyses plan, finalised prior to completion of the study. All analyses will be conducted on an intention-to-treat basis. The primary analyses will be unadjusted analyses in which binary outcomes will be compared using relative risks with 95% confidence
intervals and chi square tests and continuous outcomes will be compared with the use of mean differences and un-paired T-tests assuming that normality assumptions are meet. If normality assumptions are not met then we plan to attempt simple data transformation, such as
a logarithm transformation, and if this fails to proceed to a Mann- Whitney rank based test. Adjusted analyses will be performed using Poisson regression for binary outcomes and linear regression for continuous outcomes. Baseline covariates will include age, gender, and specialty of admission. Survival times will be compared using log-rank
tests and presented as Kaplan-Meier curves.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/04/2014
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Actual
1/04/2014
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Date of last participant enrolment
Anticipated
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Actual
13/10/2014
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Date of last data collection
Anticipated
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Actual
13/10/2014
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Sample size
Target
260
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Accrual to date
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Final
251
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Recruitment outside Australia
Country [1]
5871
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New Zealand
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State/province [1]
5871
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Wellington
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Funding & Sponsors
Funding source category [1]
288843
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Commercial sector/Industry
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Name [1]
288843
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Baxter Healthcare
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Address [1]
288843
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PO Box 88, Toongabbie (2146) , NSW
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Country [1]
288843
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Medical Research Institute of New Zealand
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Address
Private Bag 7902, Wellington 6242
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Country
New Zealand
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Secondary sponsor category [1]
287536
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None
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Name [1]
287536
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Address [1]
287536
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Country [1]
287536
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290681
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Multiregion Ethics Committee of the Health Research Council of New Zealand
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Ethics committee address [1]
290681
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c/- Ministry of Health PO Box 5013 1 The Terrace Wellington 6011 Country: New Zealand
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Ethics committee country [1]
290681
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New Zealand
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Date submitted for ethics approval [1]
290681
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Approval date [1]
290681
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12/02/2014
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Ethics approval number [1]
290681
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14/NTB/12
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Summary
Brief summary
0.9% saline has been used in clinical practice for fluid resuscitation and general fluid therapy since the 1880s. While it is the most commonly used IV resuscitation fluid in the world, recent data raise the possibility that using 0.9% saline for intravenous therapy may be related to increased blood transfusion requirement following major surgery compared to Plasma-Lyte (Registered Trademark)" 148 . Current data are insufficient to recommend clinical practice change and further data from an interventional trial are urgently needed
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Trial website
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Trial related presentations / publications
Poster presentation: A single centre nested pilot study investigating the effect on post-operative bleeding of using 0.9 % saline or plasma-lyte® 148 as crystalloid fluid therapy in adults in ICU after heart surgery. Conference: 36th International Symposium on Intensive Care and Emergency Medicine, 15/03/2016, Brussels, Belgium.
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Public notes
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Contacts
Principal investigator
Name
46758
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Dr Sumeet Reddy
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Address
46758
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Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
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Country
46758
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New Zealand
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Phone
46758
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(+64 4 8050239)
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Fax
46758
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Email
46758
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[email protected]
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Contact person for public queries
Name
46759
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Sumeet Reddy
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Address
46759
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Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
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Country
46759
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New Zealand
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Phone
46759
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(+64 4 8050239)
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Fax
46759
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Email
46759
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[email protected]
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Contact person for scientific queries
Name
46760
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Sumeet Reddy
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Address
46760
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Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
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Country
46760
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New Zealand
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Phone
46760
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(+64 4 8050239)
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Fax
46760
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Email
46760
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Overview of the study protocols and statistical analysis plan for the Saline versus Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program
2015
https://doi.org/10.1016/s1441-2772(23)01524-7
Embase
Effect of 0.9% Saline or Plasma-Lyte 148 as Crystalloid Fluid Therapy in the Intensive Care Unit on Blood Product Use and Postoperative Bleeding After Cardiac Surgery.
2017
https://dx.doi.org/10.1053/j.jvca.2017.04.023
N.B. These documents automatically identified may not have been verified by the study sponsor.
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