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The Effect of Crystalloids and Colloids on Visceral Blood Flow

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ClinicalTrials.gov Identifier: NCT01087853
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
University of Nottingham

Brief Summary:

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 or disease Intervention/treatment Phase
Fluid Overload Water Electrolyte Imbalance Acid Base Imbalance Drug: Crystalloid Drug: Colloid Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087853


Locations
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United Kingdom
Brain and Body MRI Centre, University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Dileep Lobo, MBBS MD FRCS University of Nottingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dileep Lobo, University of Nottingham
ClinicalTrials.gov Identifier: NCT01087853    
Other Study ID Numbers: 09063
2009-014774-18 ( EudraCT Number )
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011
Keywords provided by University of Nottingham:
Fluid Therapy
Water Electrolyte Imbalance
Acid Base Imbalance
Renal Circulation
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Water-Electrolyte Imbalance
Acid-Base Imbalance
Metabolic Diseases