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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
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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
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Secondary ID [1]
259663
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Nil
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Universal Trial Number (UTN)
U1111-1119-5558
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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:
Superior Mesenteric Artery Blood Flow in older Critically ill patients
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Glucose Absorption in older Critically ill patients
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Condition category
Condition code
Diet and Nutrition
259378
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
258088
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Other interventions
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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% of baseline superior mesenteric artery(SMA) flow(where 100% suggests no change in flow) using Ultrasound Doppler
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Assessment method [1]
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Timepoint [1]
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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
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Primary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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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
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Primary outcome [3]
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Blood Glucose Level measured by bedside glucometer(mmol/L)
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Assessment method [3]
262194
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Timepoint [3]
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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.
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Secondary outcome [1]
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Glucagon-like Peptide-1 via blood sample
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [2]
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Change in systemic blood pressure(mmHg) in real time via arterial line inserted into radial artery
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Assessment method [2]
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Timepoint [2]
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every 2 minutes after observation commencement for a total of 240 minutes
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Secondary outcome [3]
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Gastric Inhibitory Polypeptide(pmol/L) via blood sample
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Assessment method [3]
273306
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Timepoint [3]
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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.
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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
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Minimum age
65
Years
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Maximum age
90
Years
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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
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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
21/02/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Royal Adelaide Hospital
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Address [1]
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Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Jennifer Sim
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Address
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
257689
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Adam Deane
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Address [1]
257689
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Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country [1]
257689
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260520
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Royal Adelaide Hospital Research Ethics Committee
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Ethics committee address [1]
260520
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Ethics committee country [1]
260520
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Australia
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Date submitted for ethics approval [1]
260520
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Approval date [1]
260520
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01/02/2011
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Ethics approval number [1]
260520
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
32255
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Adam Deane
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Address
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Intensive Care Unit Research Office, Level 4
Royal Adelaide Hospital
North Terrace Adelaide
SA 5000
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Country
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Australia
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Phone
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61 8 8222 4000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Adam Deane
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Address
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Intensive Care Unit Research Office, Level 4
Royal Adelaide Hospital
North Terrace Adelaide
SA 5000
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Country
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Australia
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Phone
6430
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61 8 8222 4000
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Fax
6430
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61 8 8222 2367
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Email
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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
No additional documents have been identified.
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