ColonoscopyPhase 1NCT01250886
Acid-base Balance in Patients Undergoing Colonoscopy
A Phase 1 study testing Lactated Ringer's solution, Normal saline solution and Acetate Ringer's solution in people with Colonoscopy and Bowel Preparation, run by Mahidol University.
Trial summary
The purpose of this study is to determine whether fluid administration in patients undergoing colonoscopy should affect acid-base disorder in term of the strong ion differences. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- Lactated Ringer's solution, Normal saline solution and Acetate Ringer's solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or non-pregnant
- non-lactating female out-patient scheduled for routine colonoscopy
- over 18 years of age
- eligible for taking PEG or NaP for bowel preparation, and willing to sign informed consent.
Who cannot join
- insulin-dependant diabetes
- renal insufficiency (creatinine >2.0 mg⁄ dL)
- renal dialysis
- uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure)
- unstable angina
- untreated cardiac arrhythmia
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- ileus and⁄or acute obstruction or perforation
- ileostomy
- presence of a colostomy
- history of a partial colon resection
- active gastrointestinal bleeding.
About this study
Official title: Intravenous Fluid Administration in Patients Undergoing Colonoscopy: Double Blind, Randomised Clinical Trial of Underlying Acid-base Derangement
The purpose of this study is to determine whether fluid administration in patients undergoing colonoscopy should affect acid-base disorder in term of the strong ion differences.
Read the detailed description
This is a prospective, double-blinded, randomized control trial. The study enrolls 90 consecutive outpatients, well-prepared bowel, scheduled to undergo routine colonoscopy for screening, surveillance, or diagnosis of colorectal diseases. At the outpatient clinic, the co-researcher invites patients who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained and the first blood sample is conducted.
On the day of colonoscopy, all participants are randomized equally into three groups: Normal saline solution (NSS, n = 30) as control group, lactated Ringer's solution (LRS, n = 30) and acetated Ringer's solution (ARS, n = 30) as treatment groups. The second blood sample is obtained from patients via 20-gauge needle in either forearm immediately before an allocated intravenous (IV) fluid administered on the same site. The volume of fluid is calculated by means of Holliday and Segar formula.
The colonoscopy under total intravenous anesthesia is performed between 9:00 a.m. and 3:00 p.m. At the end of colonoscopy, the patients spontaneously wake up in the recovery room. After they gain conscious and all vital signs are stable; the intravenous fluid is off and the third blood sample is taken in the other forearm. After completion of the procedure, the patient is advised to follow the discharge instructions.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- Lactated Ringer's solution, Normal saline solution, Acetate Ringer's solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer's solutionDrug
Also called LRS
Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Normal saline solutionDrug
Also called NSS
Normal saline solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Acetate Ringer's solutionDrug
Also called ARS
Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline solution | Placebo comparator | Blood sample is obtained from patient in either forearm immediately before a Normal saline solution administered on the same site. The volume of fluid administration is calculated by means of Holliday and Segar formula. Receives: Drug: Normal saline solution |
| Lactated Ringer's solution | Active comparator | Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula. Receives: Drug: Lactated Ringer's solution |
| Acetate Ringer's solution | Active comparator | Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula. Receives: Drug: Acetate Ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Acid-base disorder as a Measure of Strong Ion Difference.
The strong ion difference (SID) is calculated by means of the differences between the positively and negatively charged strong ions in plasma. The strong ion difference affected by bowel preparation and intravenous fluid administration during colonoscopy.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2015
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phongthara Vichitvejpaisal", Mahidol University
- Investigators
- Phongthara Vichitvejpaisal, M.D., Ph.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250886
- Sponsor's protocol ID
- 456/2553(EC2)
- Status last verified
- Mar 2016
- First submitted
- 29 Nov 2010
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fluid Administration in Patients Undergoing Colonoscopy: Double Blind, Randomised Clinical Trial of Underlying Acid-base Derangement
- ClinicalTrials.gov ID
- NCT01250886
- Acronym / sponsor ID
- 456/2553(EC2)
- Conditions
- Colonoscopy, Bowel Preparation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether fluid administration in patients undergoing colonoscopy should affect acid-base disorder in term of the strong ion differences.
Detailed description
This is a prospective, double-blinded, randomized control trial. The study enrolls 90 consecutive outpatients, well-prepared bowel, scheduled to undergo routine colonoscopy for screening, surveillance, or diagnosis of colorectal diseases. At the outpatient clinic, the co-researcher invites patients who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained and the first blood sample is conducted.
On the day of colonoscopy, all participants are randomized equally into three groups: Normal saline solution (NSS, n = 30) as control group, lactated Ringer's solution (LRS, n = 30) and acetated Ringer's solution (ARS, n = 30) as treatment groups. The second blood sample is obtained from patients via 20-gauge needle in either forearm immediately before an allocated intravenous (IV) fluid administered on the same site. The volume of fluid is calculated by means of Holliday and Segar formula.
The colonoscopy under total intravenous anesthesia is performed between 9:00 a.m. and 3:00 p.m. At the end of colonoscopy, the patients spontaneously wake up in the recovery room. After they gain conscious and all vital signs are stable; the intravenous fluid is off and the third blood sample is taken in the other forearm. After completion of the procedure, the patient is advised to follow the discharge instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal saline solution | Placebo comparator | Drug: Normal saline solutionBlood sample is obtained from patient in either forearm immediately before a Normal saline solution administered on the same site. The volume of fluid administration is calculated by means of Holliday and Segar formula. |
| Lactated Ringer's solution | Active comparator | Drug: Lactated Ringer's solutionLactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula. |
| Acetate Ringer's solution | Active comparator | Drug: Acetate Ringer's solutionAcetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or non-pregnant
- non-lactating female out-patient scheduled for routine colonoscopy
- over 18 years of age
- eligible for taking PEG or NaP for bowel preparation, and willing to sign informed consent.
Key exclusion criteria (11 listed)
- insulin-dependant diabetes
- renal insufficiency (creatinine >2.0 mg⁄ dL)
- renal dialysis
- uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure)
- unstable angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated Ringer's solutionAlso: LRSLactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula. | Drug | Lactated Ringer's solution |
| Normal saline solutionAlso: NSSNormal saline solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula. | Drug | Normal saline solution |
| Acetate Ringer's solutionAlso: ARSAcetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula. | Drug | Acetate Ringer's solution |
Primary outcome
Number of Patients with Acid-base disorder as a Measure of Strong Ion Difference.
Time frame: 3 days
The strong ion difference (SID) is calculated by means of the differences between the positively and negatively charged strong ions in plasma. The strong ion difference affected by bowel preparation and intravenous fluid administration during colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phongthara Vichitvejpaisal, M.D., Ph.D. principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactated Ringer's solution, Normal saline solution and Acetate Ringer's solution in people with Colonoscopy and Bowel Preparation, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Acid-base disorder as a Measure of Strong Ion Difference. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.