Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000218998
Ethics application status
Approved
Date submitted
23/02/2011
Date registered
28/02/2011
Date last updated
28/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of critical illness on blood flow to the gastrointestinal tract during feeding and the absorption of sugar in older patients
Scientific title
The effect of critical illness on glucose absorption, superior mesenteric artery blood flow and systemic blood pressure during intraduodenal glucose infusion in older patients
Secondary ID [1] 259663 0
Nil
Universal Trial Number (UTN)
U1111-1119-5558
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superior Mesenteric Artery Blood Flow in older Critically ill patients 261232 0
Glucose Absorption in older Critically ill patients 261235 0
Condition category
Condition code
Diet and Nutrition 259378 259378 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A nasoduodenal feeding tube will be inserted through the nose and positioned in the proximal duodenum using the Cortrak device. Between t = 60 and 120 min infusion of 0.9% saline into the duodenum. At t = 120 min, an intraduodenal glucose infusion will begin (32 g glucose together with 3 g 3-oxy-methyl-D-glucose (3-OMG) in water to a total volume of 120mL, and infused over 60 minutes ~ 2 kcal/min). Participants will undergo this intervention once, after consent has been granted by the next of kin.
Intervention code [1] 258088 0
Other interventions
Comparator / control treatment
Healthy Volunteers will undergo the same process of having saline, glucose and 3-OMG infused via a nasoduodenal feeding tube like the participants in the intervention group.

Once the nasoduodenal tube has been inserted(t=0), a one hour observational period will commence. At t=60, a saline infusion will begin for a period of 60 minutes, thus enabling the subject to be his/her own control.

The control will be administered to the participants once.

The duration of each session is 4 hours from insertion to removal of the nasoduodenal tube in healthy volunteers.
Control group
Active

Outcomes
Primary outcome [1] 262190 0
% of baseline superior mesenteric artery(SMA) flow(where 100% suggests no change in flow) using Ultrasound Doppler
Timepoint [1] 262190 0
SMA will be measured at baseline and at 55, 65, 75, 90, 125, 135, 150, 165, 180, 195, 210, 225, 240 min after observation commencement
Primary outcome [2] 262191 0
Rate of Glucose Absorption as is indicated by the area under the serum 3-OMG concentration curve, peak concentration and time to peak. Blood samples will be collected and analysed for plasma 3-OMG concentration using High Performance Liquid Chromatography
Timepoint [2] 262191 0
At timepoints 60, 90, 120 minutes for baseline levels and after 3-OMG infusion at timepoints 125, 135, 150, 165, 180, 195, 210 225, 240 minutes. Urine collected from 240-480min to ensure there are no false increases in apparent absorption
Primary outcome [3] 262194 0
Blood Glucose Level measured by bedside glucometer(mmol/L)
Timepoint [3] 262194 0
At timepoints 60, 90, 120 minutes for baseline levels and after 3-OMG infusion at timepoints 125, 135, 150, 165, 180, 195, 210 225, 240 minutes.
Secondary outcome [1] 273301 0
Glucagon-like Peptide-1 via blood sample
Timepoint [1] 273301 0
At timepoints 60, 90, 120 minutes for baseline levels and after 3-OMG infusion at timepoints 125, 135, 150, 165, 180, 195, 210 225, 240 minutes.
Secondary outcome [2] 273302 0
Change in systemic blood pressure(mmHg) in real time via arterial line inserted into radial artery
Timepoint [2] 273302 0
every 2 minutes after observation commencement for a total of 240 minutes
Secondary outcome [3] 273306 0
Gastric Inhibitory Polypeptide(pmol/L) via blood sample
Timepoint [3] 273306 0
At timepoints 60, 90, 120 minutes for baseline levels and after 3-OMG infusion at timepoints 125, 135, 150, 165, 180, 195, 210 225, 240 minutes.

Eligibility
Key inclusion criteria
Critically ill mechanically ventilated patients > 65 years of age who are receiving, or suitable to receive, enteral nutrition

Healthy volunteers >65 years of age
Minimum age
65 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any contraindication to enteral feeding, previous surgery to the oesophagus, stomach or duodenum, any gastrointestinal surgery during their current hospital admission, patients with known Diabetes mellitus, patients receiving antihypertensive medications, patients receiving exogenous catecholamine(noradrenaline and adrenaline) > 30 ug/min, Body Mass Index >32 kg/m2, Patients requiring a mean arterial blood pressure > 80 mmHg

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. The two groups created are the patient group and the control group. Healthy volunteers are allocated to the control group. ICU patients who fit the inclusion criteria are recruited to the patient group from the Intensive Care Unit at the Royal Adelaide Hospital and consent given by the next of kin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258552 0
Hospital
Name [1] 258552 0
Royal Adelaide Hospital
Country [1] 258552 0
Australia
Primary sponsor type
Individual
Name
Jennifer Sim
Address
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 257689 0
Individual
Name [1] 257689 0
Adam Deane
Address [1] 257689 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 257689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260520 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 260520 0
Ethics committee country [1] 260520 0
Australia
Date submitted for ethics approval [1] 260520 0
Approval date [1] 260520 0
01/02/2011
Ethics approval number [1] 260520 0

Summary
Brief summary
The primary purpose of the study is to investigate the effect of critical illness on blood flow to the gastrointestinal tract during feeding and the absorption of sugar in older patients. We hypothesize that the change in blood flow to the gastrointestinal tract during feeding and the absorption of sugar in ICU patients will be less than that of healthy volunteers. This may indicate a possible mechanism for malabsorption during critical illness or alternatively, when to start feeding critically ill patients via the gastrointestinal route.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32255 0
Address 32255 0
Country 32255 0
Phone 32255 0
Fax 32255 0
Email 32255 0
Contact person for public queries
Name 15502 0
Dr Adam Deane
Address 15502 0
Intensive Care Unit Research Office, Level 4
Royal Adelaide Hospital
North Terrace Adelaide
SA 5000
Country 15502 0
Australia
Phone 15502 0
61 8 8222 4000
Fax 15502 0
Email 15502 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 6430 0
Dr Adam Deane
Address 6430 0
Intensive Care Unit Research Office, Level 4
Royal Adelaide Hospital
North Terrace Adelaide
SA 5000
Country 6430 0
Australia
Phone 6430 0
61 8 8222 4000
Fax 6430 0
61 8 8222 2367
Email 6430 0
adam.deane@adelaide.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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