Acid-base Balance in Patients Undergoing Colonoscopy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Phongthara Vichitvejpaisal", Mahidol University
ClinicalTrials.gov Identifier:
NCT01250886
First received: November 29, 2010
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Colonoscopy
Bowel Preparation
Drug: Lactated Ringer's solution
Drug: Normal saline solution
Drug: Acetate Ringer's solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Fluid Administration in Patients Undergoing Colonoscopy: Double Blind, Randomised Clinical Trial of Underlying Acid-base Derangement

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Number of Patients with Acid-base disorder as a Measure of Strong Ion Difference. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 90
Study Start Date: December 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250886

Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Phongthara Vichitvejpaisal, M.D., Ph.D. Mahidol University
  More Information

No publications provided

Responsible Party: Phongthara Vichitvejpaisal", Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01250886     History of Changes
Other Study ID Numbers: 456/2553(EC2)
Study First Received: November 29, 2010
Last Updated: September 12, 2012
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014