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The Effect of Crystalloids and Colloids on Visceral Blood Flow

This study has been completed.
Sponsor:
Information provided by:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01087853
First received: March 15, 2010
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
  Purpose

Patients often require fluid replacement during and after an operation. This is usually given through veins in the arm using an intravenous cannula and doctors have traditionally used fluid containing sodium chloride (saline). However accumulating evidence suggests that large infusions of saline are associated with adverse physiological effects including acidification of the blood and a rise in potassium and chloride levels. Studies in animals have shown that high levels of chloride in the blood and excess saline can cause blood vessels in the kidney to constrict leading possibly to a decrease in kidney function. Improvement in acid-base balance and kidney function may be observed with balanced solutions containing constituents that are more closely matched to the body's own fluid composition. However, little is known about the physiological effects of these solutions as they have only recently been developed.

Magnetic resonance imaging (MRI) is a radiological modality which can now assess blood flow and supply of the kidney noninvasively without the need for the injection of radiological dyes known as contrast agents. This is now of major importance due to the possible adverse effects of MRI contrast agents leading to Nephrogenic Systemic Fibrosis (NSF), a progressive disease which has been observed in some kidney patients after receiving 'gadolinium based' contrast agents. This has therefore led to increased interest and demand for noncontrast based imaging methods. In this study we aim to compare the effects of balanced versus unbalanced fluid infusions in healthy human volunteers:

We will aim to measure:

  1. Blood biochemical composition and acidity
  2. Kidney function and supply as measured by dynamic MRI

Condition Intervention Phase
Fluid Overload
Water Electrolyte Imbalance
Acid Base Imbalance
 Drug: Crystalloid
Drug: Colloid
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Balanced and Unbalanced Crystalloids and Colloids on Serum Biochemistry and Visceral Blood Flow: A Two Phase, Double Blind, Randomised Crossover Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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. [ Time Frame: Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in blood volume, renal and superior mesenteric arterial blood flow and vessel diameter. [ Time Frame: Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phase A1: Plasmalyte
Plasmalyte
 Drug: Crystalloid
2 litres intravenous infusion in 60 minutes
Active Comparator: Phase A2: 0.9% Saline
0.9% Saline
 Drug: Crystalloid
2 litres intravenous infusion in 60 minutes
Active Comparator: Phase B1: PlasmaVolume
PlasmaVolume
 Drug: Colloid
1 litre intravenous infusion over 30 minutes
Active Comparator: Phase B2: Voluven
Voluven
 Drug: Colloid
1 litre intravenous infusion over 30 minutes

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Male
  • Aged between 18 and 40 years
  • Weight between 65 and 80 kilograms
  • Able to give informed consent

Exclusion Criteria:

  • Chronic medical conditions
  • Use of any regular medications
  • History of substance abuse
  • Known hypersensitivity to study infusion fluids
  • Contraindications to MRI scanning
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087853

Locations
United Kingdom
Brain and Body MRI Centre, University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Dileep Lobo, MBBS MD FRCS University of Nottingham
  More Information

No publications provided by University of Nottingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dileep Lobo, University of Nottingham
ClinicalTrials.gov Identifier: NCT01087853     History of Changes
Other Study ID Numbers: 09063, 2009-014774-18
Study First Received: March 15, 2010
Last Updated: May 31, 2011
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Nottingham:
Fluid Therapy
Water Electrolyte Imbalance
Acid Base Imbalance
Renal Circulation
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Acid-Base Imbalance
Water-Electrolyte Imbalance
Water Intoxication
 Metabolic Diseases
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on June 17, 2013