The effects of balanced and unbalanced crystalloids and colloids on serum biochemistry and visceral blood flow: A two-phase, double-blind, randomised cross-over study - The Effect of Crystalloids and Colloids on Visceral Blood Flow

• Conditions: This is a healthy volunteer study investigating the effect of balanced and unbalanced fluid infusions on serum electrolytes, osmolality and acid/base balance. In addition we are examining the role of balanced and unbalanced fluid infusions on renal perfusion and function.

• Registration Number: EUCTR2009-014774-18-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

HealthyMaleAged between 18 and 40 years Weight between 65 and 80kg Able to give informed consent
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Chronic medical conditions Any regular medications History of substance abuse Those individuals with a contraindication to MRI scanning: Metal implants Aneurysm clips Pacemaker or artificial heart valves Cochlear implants Claustrophobia Tattoos

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the differential impact of balanced versus unbalanced fluid infusions on serum electrolyte, osmolality and acid base status.;Secondary Objective: To determine the differential impact of balanced versus unbalanced fluid infusion on renal function as measured by urinary NGAL and functional MRI.;Primary end point(s): To determine the differential impact of balanced versus unbalanced fluid infusion on serum electrolyte, osmolality and acid base status. The primary end point of each phase of this study will be a 6 mmol difference in serum chloride concentration after infusion of the balanced and unbalanced crystalloids and colloids.