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Acid-base Balance in Patients Undergoing Colonoscopy

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ClinicalTrials.gov Identifier: NCT01250886
Recruitment Status : Unknown
Verified March 2016 by Phongthara Vichitvejpaisal", Mahidol University.
Recruitment status was:  Enrolling by invitation
First Posted : December 1, 2010
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Phongthara Vichitvejpaisal", Mahidol University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Bowel Preparation Drug: Lactated Ringer's solution Drug: Normal saline solution Drug: Acetate Ringer's solution Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Fluid Administration in Patients Undergoing Colonoscopy: Double Blind, Randomised Clinical Trial of Underlying Acid-base Derangement
Study Start Date : December 2010
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Normal saline solution
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.
 Drug: Normal saline solution
Normal saline solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Other Name: NSS
Active Comparator: Lactated Ringer's solution
Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
 Drug: Lactated Ringer's solution
Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Other Name: LRS
Active Comparator: Acetate Ringer's solution
Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
 Drug: Acetate Ringer's solution
Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
Other Name: ARS


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • ileus and⁄or acute obstruction or perforation
  • ileostomy
  • presence of a colostomy
  • history of a partial colon resection
  • active gastrointestinal bleeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250886


Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Phongthara Vichitvejpaisal, M.D., Ph.D. Mahidol University
More Information
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Responsible Party: Phongthara Vichitvejpaisal", Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01250886    
Other Study ID Numbers: 456/2553(EC2)
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Pharmaceutical Solutions