Acid-base Balance in Patients Undergoing Colonoscopy

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.

Study Overview

• Status: Unknown
• Conditions: Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: Normal saline solution; Drug: Lactated Ringer's solution; Drug: Acetate Ringer's solution

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: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: ARS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Phongthara Vichitvejpaisal, M.D., Ph.D., Mahidol University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ANTICIPATED): April 1, 2016

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 29, 2010
• First Posted (ESTIMATE): December 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 456/2553(EC2)