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Acid-base Balance in Patients Undergoing Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE December 1, 2010
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE December 2010
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2010)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acid-base Balance in Patients Undergoing Colonoscopy
Official Title  ICMJE Intravenous Fluid Administration in Patients Undergoing Colonoscopy: Double Blind, Randomised Clinical Trial of Underlying Acid-base Derangement
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Colonoscopy
  • Bowel Preparation
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Normal saline solution
  • 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.
    Intervention: Drug: Lactated Ringer's solution
  • 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.
    Intervention: Drug: Acetate Ringer's solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 29, 2010)		 90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01250886
Other Study ID Numbers  ICMJE 456/2553(EC2)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Phongthara Vichitvejpaisal", Mahidol University
Original Responsible Party Professor Phongthara Vichitvejpaisal, Mahidol University
Current Study Sponsor  ICMJE Mahidol University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Phongthara Vichitvejpaisal, M.D., Ph.D. Mahidol University
PRS Account Mahidol University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP