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
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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:
- Blood biochemical composition and acidity
- 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 |

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
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Drug: Crystalloid
2 litres intravenous infusion in 60 minutes |
Active Comparator: Phase A2: 0.9% Saline
0.9% Saline
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Drug: Crystalloid
2 litres intravenous infusion in 60 minutes |
Active Comparator: Phase B1: PlasmaVolume
PlasmaVolume
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Drug: Colloid
1 litre intravenous infusion over 30 minutes |
Active Comparator: Phase B2: Voluven
Voluven
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Drug: Colloid
1 litre intravenous infusion over 30 minutes |
- 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 ]
- 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 |
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

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
United Kingdom | |
Brain and Body MRI Centre, University of Nottingham | |
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD |
Principal Investigator: | Dileep Lobo, MBBS MD FRCS | University of Nottingham |
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 |
Fluid Therapy Water Electrolyte Imbalance Acid Base Imbalance Renal Circulation Magnetic Resonance Imaging |
Acid-Base Imbalance Water-Electrolyte Imbalance Metabolic Diseases |