Acid-base Balance in Patients Undergoing Colonoscopy

NCT01250886 | Unknown Phase 1 DMC

• 1 other identifier: 456/2553(EC2)
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy; Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

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.

Drug: Acetate Ringer's solution

Interventions

Lactated Ringer's solution DRUG

Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.

Also known as: LRS

Lactated Ringer's solution

Normal saline solution DRUG

Normal saline solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.

Also known as: NSS

Normal saline solution

Acetate Ringer's solution DRUG

Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.

Also known as: ARS

Acetate Ringer's solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Interventions

Ringer's Lactate; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Phongthara Vichitvejpaisal, M.D., Ph.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 1, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03