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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014774-18-GB
Enrollment
Unknown
Registered
2009-11-09
Start date
2009-10-29
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Plasma-Lyte 148 (pH 7.4) Solution for Infusion Product Name: Plasma-Lyte 148 (pH 7.4) Solution for Infusion Product Code: PL 00116/0332 Pharmaceutical Form: Intravenous infusion INN or Pro

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026