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Trial registered on ANZCTR


Registration number
ACTRN12614001071617
Ethics application status
Approved
Date submitted
24/09/2014
Date registered
7/10/2014
Date last updated
20/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The safe administration of large volume of intravenous fluids in colonoscopy patients to prevent hypotension- guided by patients' level of fluid tolerance on inferior vena cava ultrasound.
Scientific title
The safe administration of large volume of intravenous fluids in colonoscopy patients to prevent hypotension- guided by patients' level of fluid tolerance on inferior vena cava ultrasound.
Secondary ID [1] 285397 0
Nil
Universal Trial Number (UTN)
U1111-1162-1985
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intra-operative hypotension in elective colonoscopy patients. 293134 0
Condition category
Condition code
Anaesthesiology 293403 293403 0 0
Anaesthetics
Cardiovascular 293451 293451 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hartmann's solution 30ml/kg intravenously pre-operatively, titrated according to level of fluid tolerance on echocardiography.
Intervention code [1] 290309 0
Treatment: Other
Intervention code [2] 290340 0
Treatment: Drugs
Comparator / control treatment
No treatment.
Control group
Active

Outcomes
Primary outcome [1] 293230 0
Incidence of intra-operative hypotension as measured by automatic sphygmomanometer.
Timepoint [1] 293230 0
For the duration of the procedure.
Secondary outcome [1] 310645 0
Nil
Timepoint [1] 310645 0
Nil.

Eligibility
Key inclusion criteria
All patients presenting for elective colonoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal to participate.
2. Language barrier.
3. Medical contraindications (e.g. severe uncontrolled congestive cardiac failure/renal failure)
4. Time constraints (e.g. administrative pressure to get the elective colonoscopy list finished on time).

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)
All potential subjects will be made aware of participation in this study by verbal information (staff nurse and investigators) and written information (patient information sheet).

Should subject agrees to enrolment in this study, he/she will be randomised to either the Treatment Group or the Control Group based on computer-generated central randomisation. Allocation is thus concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated algorithm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We retrospectively audited intraoperative blood pressures of 200 colonoscopy patients prior to the actual study. We used previous investigators’ criteria to define hypotension, which is a drop in systolic blood pressure of 25% or more from the baseline, and that one reading was sufficient to define hypotension. Of the 200 patients, 101 had hypotension (50.5%), and 99 did not (49.5%). Based on the control event rate of 50.5% and an estimated experimental event rate as low as 25%, a sample size requirement to be 60 patients per group provides 80% power to detect this difference, assuming a Type 1 error rate of 5%.
Differences between groups at baseline were assessed using t-tests for normally distributed variables and chi-square tests or Fisher exact tests for discrete variables, as appropriate. The difference in incidence between groups was then assessed using a chi-squared test without continuity correction.
We also conducted a multivariable secondary analysis on hypotension, adjusting for group assignment, gender, age, American Society of Anesthesiologist (ASA) status, body mass index (BMI), systolic blood pressure, right atrial pressures, diabetes mellitus, presence of hypertension, hypercholesterolaemia, cardiac comorbidities, renal comorbidities, and respiratory comorbidities, using logistic regression analysis. Model fit was assessed using the Hosmer-Lemeshow statistic. A p-value less than 0.05 (two-tailed) was accepted as significant with 95% confidence intervals reported. Analyses were conducted using Stata 14.0 (StataCorp, College Station, Texas.)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2014
Actual
5/11/2014
Date of last participant enrolment
Anticipated
31/01/2015
Actual
16/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8730 0
5290 - Mount Gambier

Funding & Sponsors
Funding source category [1] 290003 0
Self funded/Unfunded
Name [1] 290003 0
N/A
Country [1] 290003 0
Primary sponsor type
Individual
Name
Dr. Peter Reid
Address
Mount Gambier Hospital
276-300 Wehl Street North,
Mount Gambier SA 5290
Country
Australia
Secondary sponsor category [1] 288686 0
None
Name [1] 288686 0
Address [1] 288686 0
Country [1] 288686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291709 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 291709 0
Flinders Medical Centre
Flinders Drive, Bedford Park 5042 SA
Ethics committee country [1] 291709 0
Australia
Date submitted for ethics approval [1] 291709 0
05/09/2014
Approval date [1] 291709 0
08/09/2014
Ethics approval number [1] 291709 0
HREC/14/SAC/243

Summary
Brief summary
Colonoscopy patients are often "dry" or dehydrated as a result of the bowel preparation. This often results in a drop in blood pressure during the procedure. A study in 2006 showed that by giving patients 15ml/kg of fluid, it did not result in improvement of blood pressures, and it was postulated that the volume infused could have been insufficient. In our study, we plan to give 30ml/kg of fluid to colonoscopy patients before their procedure, as we hypothesise that 30ml/kg may be enough to prevent or reduce the drop in blood pressures. We aim to do this by using echocardiography (taking a picture of the heart) to titrate fluids so that patients will not be overloaded with fluids.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 193 193 0 0
/AnzctrAttachments/367156-Ethics Approval (APPROVED by SAC HREC).pdf

Contacts
Principal investigator
Name 51682 0
Dr Peter Reid
Address 51682 0
Mount Gambier Hospital
276-300 Wehl Street North
Mount Gambier SA 5290
Country 51682 0
Australia
Phone 51682 0
+61887211200
Fax 51682 0
Email 51682 0
[email protected]
Contact person for public queries
Name 51683 0
U-Jun Koh
Address 51683 0
Mount Gambier Hospital
276-300 Wehl Street North
Mount Gambier SA 5290
Country 51683 0
Australia
Phone 51683 0
+61887211200
Fax 51683 0
Email 51683 0
[email protected]
Contact person for scientific queries
Name 51684 0
U-Jun Koh
Address 51684 0
Mount Gambier Hospital
276-300 Wehl Street North
Mount Gambier SA 5290
Country 51684 0
Australia
Phone 51684 0
+61887211200
Fax 51684 0
Email 51684 0
[email protected]

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.