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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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
Cardiovascular 293451 293451 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
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

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
Timepoint [1] 310645 0

Key inclusion criteria
All patients presenting for elective colonoscopy.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 8730 0
5290 - Mount Gambier

Funding & Sponsors
Funding source category [1] 290003 0
Self funded/Unfunded
Name [1] 290003 0
Address [1] 290003 0
Country [1] 290003 0
Primary sponsor type
Dr. Peter Reid
Mount Gambier Hospital
276-300 Wehl Street North,
Mount Gambier SA 5290
Secondary sponsor category [1] 288686 0
Name [1] 288686 0
Address [1] 288686 0
Country [1] 288686 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 291709 0
Approval date [1] 291709 0
Ethics approval number [1] 291709 0

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

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
Phone 51682 0
Fax 51682 0
Email 51682 0
Contact person for public queries
Name 51683 0
Dr U-Jun Koh
Address 51683 0
Mount Gambier Hospital
276-300 Wehl Street North
Mount Gambier SA 5290
Country 51683 0
Phone 51683 0
Fax 51683 0
Email 51683 0
Contact person for scientific queries
Name 51684 0
Dr U-Jun Koh
Address 51684 0
Mount Gambier Hospital
276-300 Wehl Street North
Mount Gambier SA 5290
Country 51684 0
Phone 51684 0
Fax 51684 0
Email 51684 0

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