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Trial registered on ANZCTR


Registration number
ACTRN12615000466549
Ethics application status
Approved
Date submitted
5/03/2015
Date registered
13/05/2015
Date last updated
13/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative effect of resuscitation with hypertonic saline versus normal saline after extracorporeal circulation during cardiovascular surgery in the Intensive Care Unit (ICU)
Scientific title
Comparative effect of resuscitation with hypertonic saline versus normal saline on lactate clearance in patients hospitalized in ICU that underwent extracorporeal circulation during valve replacement or coronary artery bypass grafting
Secondary ID [1] 286223 0
none
Universal Trial Number (UTN)
U1111-1167-4074
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crystalloid resuscitation after valve replacement surgery and coronary artery bypass surgery that underwent extracorporeal circulation 294269 0
Condition category
Condition code
Anaesthesiology 294588 294588 0 0
Other anaesthesiology
Cardiovascular 295127 295127 0 0
Other cardiovascular diseases
Surgery 295128 295128 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We administer intravenously infused over 30 minutes Hypertonic Saline with a concentration of 7.5% in a dose of 4 cc x kg of predicted body weight when the patients arrive to the ICU after a replacement valve surgery or a coronary artery bypass graft surgery that underwent extracorporeal circulation.
Intervention code [1] 291239 0
Treatment: Drugs
Comparator / control treatment
We administer intravenously infused over 30 minutes Normal Saline with a concentration of 0.9% in a dose of 4 cc x kg of predicted body weight when the patients arrive to the ICU after a replacement valve surgery or a coronary artery bypass graft surgery that underwent extracorporeal circulation.
Control group
Active

Outcomes
Primary outcome [1] 294357 0
The blood lactate sample was obtained from central venous catheter immediately after the admission of the patient in the ICU and then again after 6 hours, 12 hours and 24 hours.

Lactate is measured in the laboratory by chemical oxidation method.
Timepoint [1] 294357 0
Assessed on admission of the patient in the ICU and then again after 6 hours, 12 hours and 24 hours.
Secondary outcome [1] 313095 0
The cardiac index was measured by the thermodilution principle with a pulmonary artery catheter after the admission of the patient in the ICU and then again at 30 minutes, 4 hours, 6 hours, 12 hours and 24 hours.
Timepoint [1] 313095 0
Assessed on admission of the patient in the ICU and then again at 30 minutes, 4 hours, 6 hours, 12 hours and 24 hours.
Secondary outcome [2] 313096 0
The sample of mixed venous oxygen saturation was obtained with a pulmonary artery catheter after the admission of the patient in the ICU and then again at 30 minutes, 4 hours, 6 hours, 12 hours and 24 hours.

I - Stat system was used for measuring the mixed venous oxygen saturation.
Timepoint [2] 313096 0
Assessed on admission of the patient in the ICU and then again at 30 minutes, 4 hours, 6 hours, 12 hours and 24 hours.
Secondary outcome [3] 313097 0
ICU hospitalization length
Timepoint [3] 313097 0
time of ICU hospitalisation
Secondary outcome [4] 313098 0
mortality
Timepoint [4] 313098 0
28 days

Eligibility
Key inclusion criteria
Patients with signed informed consent older than 18 years old
Patients admitted in the ICU after valve replacement surgery or coronary artery bypass surgery that underwent extracorporeal circulation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that withdraw the informed consent by himself or by their family at any time during the intervention
Heart transplant surgery
Patients that do not fulfill the study protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We used numbered containers without label of crystalloid solution to be used in both groups of the trial, since the 7.5% hypertonic saline solution and the normal saline solution are alike, neither the patient, medical staff or the investigators were aware of what was the solution used during the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization using a random number generator (Ralloc Stata Co. 8,2)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6690 0
Colombia
State/province [1] 6690 0
Antioquia/Medellin

Funding & Sponsors
Funding source category [1] 290825 0
Self funded/Unfunded
Name [1] 290825 0
Address [1] 290825 0
Country [1] 290825 0
Primary sponsor type
Individual
Name
Ray Mendoza Franco
Address
Hospital San Vicente Fundacion
Calle 64 # 51 D - 154
Medellin/Colombia
Country
Colombia
Secondary sponsor category [1] 289512 0
Individual
Name [1] 289512 0
Luis Horacio Atehortua Lopez
Address [1] 289512 0
Hospital San Vicente Fundacion
Calle 64 # 51 D - 154
Medellin/Colombia
Country [1] 289512 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292493 0
Comite de Etica Medica del Hospital San Vicente Fundacion
Ethics committee address [1] 292493 0
Antioquia/Medellin
Street 64 # 51D - 38
Ethics committee country [1] 292493 0
Colombia
Date submitted for ethics approval [1] 292493 0
21/12/2012
Approval date [1] 292493 0
26/02/2013
Ethics approval number [1] 292493 0
2013030305

Summary
Brief summary
This is a randomized double blind controlled trial that compares 7.5% hypertonic saline solution versus normal saline solution, in the resuscitation of the patients that underwent extracorporeal circulation surgery once they arrive in the ICU. The primary endpoint was to assess the lactate clearance within each arm of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55158 0
Prof Luis Horacio Atehortua Lopez
Address 55158 0
Hospital San Vicente Fundacion
Antioquia/Medellin Street 64 Number 51 D - 154.
Country 55158 0
Colombia
Phone 55158 0
+573177891868
Fax 55158 0
Email 55158 0
lhatehortua@gmail.com
Contact person for public queries
Name 55159 0
Mr Ray Mendoza Franco
Address 55159 0
Centros Especializados San Vicente Fundacion
Rionegro/Antioquia/ Colombia
Vereda La Convencion, Via Aeropuerto Llanogrande Km 2.3.
Country 55159 0
Colombia
Phone 55159 0
+573006548025
Fax 55159 0
Email 55159 0
ray.mendoza@rocketmail.com
Contact person for scientific queries
Name 55160 0
Mr Ray Mendoza Franco
Address 55160 0
Centros Especializados San Vicente Fundacion
Rionegro/Antioquia/ Colombia
Vereda La Convencion, Via Aeropuerto Llanogrande Km 2.3.
Country 55160 0
Colombia
Phone 55160 0
+573006548025
Fax 55160 0
Email 55160 0
ray.mendoza@rocketmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary