Advertisement

Topics

The Effect of Crystalloids and Colloids on Visceral Blood Flow

2014-08-27 03:15:11 | BioPortfolio

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

Description

Type of Study: Two phase double blind, randomised crossover study. In phase A (crystalloid), we will compare the effects of Plasmalyte 148 with 0.9% saline and in phase B (colloid) we will compare the effects of PVR with Voluven.

Participants will either be involved in phase A or phase B not both. In each phase participants will receive a randomly assigned fluid and then the comparator fluid 1 week later.

Subject selection: 24 healthy, male volunteers, (12 for each phase) between the age of 18 and 40, and weighing between 65 and 80 kg will be recruited for of the study. Informed consent will be obtained before entering volunteers into the study.

Study Protocol: Volunteers will report for the study at 09.00 hours after a fast from midnight and having abstained from alcohol, nicotine, tea and coffee for at least 24 hours. After voiding of the bladder, height will recorded to the nearest 0.01 m, weight measured to the nearest 0.1 kg using Avery 3306ABV scales (Avery Berkel, Royston, UK), and body mass index calculated.

Any urine passed over a 24 hour period from the start of the infusion will be collected for measurement of creatinine clearance, osmolality and electrolytes. Two venous cannulae will be inserted, one in each forearm and blood will be sampled for full blood count, haemoglobin, electrolytes, creatinine, albumin and osmolality. A venous blood gas sample will also be obtained to calculate base excess. Serum and urinary osmolality will be measured on a Fiske 2400 Osmometer (Vitech Scientific Ltd., Partridge Green, West Sussex, UK) using a freezing point depression method which has a coefficient of variance (CV) of 1.2%. A Vitros 950 analyser (Ortho Clinical Diagnostics, Amersham, UK) will be used to measure serum sodium (CV 0.6%), potassium (CV 1.0%), magnesium, chloride (CV 1.1%), bicarbonate, (CV 4.0%), urea (CV 2.0%) and albumin (CV 1.6%). Strong ion difference will be calculated by subtracting the serum chloride concentration from the sum of the serum concentrations of sodium and potassium.28 Urinary sodium (CV 1.5%) and potassium (CV 1.5%) will be assayed on a Vitros 250 analyser (Ortho Clinical Diagnostics, Amersham, UK). Haematological parameters will be measured on a Sysmex SE 9500 Analyser (Sysmex UK Ltd., Milton Keynes, UK) using direct current hydrodynamic focusing and cumulative pulse height detection. The CV for haemoglobin and packed cell volume estimation is 11.5%.

In Phase A, 12 subjects will receive 2 litres of 0.9% saline BP (Baxter Health Care, Thetford, UK) or Plasmalyte® (Baxter Health Care, Thetford, UK). The assignment of the initial infused solution will be random followed by the alternate solution at crossover. The crystalloid solution will be infused in the supine position over 60 minutes.

In Phase B, 12 subjects will receive 1 litre of PlasmaVolume® (Baxter Health Care, Thetford, UK) or Voluven® (Fresenius Kabi, Bad Homburg, Germany). The initial infused solution will be randomly assigned and the subject will receive the alternate solution at the crossover timepoint. The starch solution will be infused in the supine position over 30 minutes. A nurse who will not be involved in the study will mask all labels and administration sets on the infusion bags with opaque tape and also perform the randomisation. Randomisation will performed using sequentially numbered paired sealed opaque envelopes. The aforementioned blood tests will be repeated at 30/60 minute intervals for 4 hours. Subjects will be encouraged to void urine as the need arises, and on completion of the study. In addition to laboratory data, time to first void and void volume will be recorded. Postinfusion urine will be pooled and analysed for osmolality, pH and concentrations of electrolytes and NGAL. The crossover experiment will be repeated with the alternate infusion not used in the first study, 7-10 days later. Participation in the crossover phase will be postponed one week if the baseline laboratory work shows continued effect of hemodilution or phlebotomy with a hematocrit decrease of 3% or greater from the first infusion baseline.

Monitoring of volunteers: Pulse oximetry will be performed continuously during the infusion. Blood pressure will be measured every 15 min for the first two hours and then every 30 min until the end of the study. Infusions will be stopped if there is any evidence of hypersensitivity or anaphylactic reactions or for the following:

The pulse rate rises above 110/minute or falls below 50/minute. The SaO2 falls below 92% The blood pressure rises above 140 mm Hg systolic or 95 mm Hg diastolic The blood pressure falls below 90 mm Hg systolic or 55 mm Hg diastolic The volunteer expresses the desire to have the infusion stopped.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Fluid Therapy

Intervention

Crystalloid, Colloid

Location

Brain and Body MRI Centre, University of Nottingham
Nottingham
Nottinghamshire
United Kingdom
NG7 2RD

Status

Recruiting

Source

University of Nottingham

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:11-0400

Clinical Trials [568 Associated Clinical Trials listed on BioPortfolio]

A Comparison of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation

Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution is the current recommended initial fluid resuscitation. However, this kind of fluid has high vol...

Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery perfo...

The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation

The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.

Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps

Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours. Intra- and postoperative goal-directed fl...

The Effect of the Timing of Colloid and Cristaloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section

Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of cristalloid and colloid in...

PubMed Articles [11104 Associated PubMed Articles listed on BioPortfolio]

Crystalloid fluid choice in the critically ill : Current knowledge and critical appraisal.

Intravenous infusion of crystalloid solutions is one of the most frequently administered medications worldwide. Available crystalloid infusion solutions have a variety of compositions and have a maj...

Intravenous crystalloid fluid for acute alcoholic intoxication prolongs emergency department length of stay.

Acute alcohol intoxication is often treated in emergency departments by intravenous crystalloid fluid (IVF), but it is not clear that this shortens the time to achieving sobriety. The study aim was to...

Colloids and the Microcirculation.

Colloid solutions have been advocated for use in treating hypovolemia due to their expected effect on improving intravascular retention compared with crystalloid solutions. Because the ultimate desire...

Are we close to the ideal intravenous fluid?

The approach to i.v. fluid therapy for hypovolaemia may significantly influence outcomes for patients who experience a systemic inflammatory response after sepsis, trauma, or major surgery. Currently,...

The use of crystalloids in traumatic brain injury.

Fluid therapy is one of the most important treatments in patients with traumatic brain injury (TBI) as both hypo- and hypervolaemia can cause harm. The main goals of fluid therapy for patients with TB...

Medical and Biotech [MESH] Definitions

Therapy whose basic objective is to restore the volume and composition of the body fluids to normal with respect to WATER-ELECTROLYTE BALANCE. Fluids may be administered intravenously, orally, by intermittent gavage, or by HYPODERMOCLYSIS.

Fluid collected from nipple by gentle aspiration. The fluid contains cells and extracellular fluid from the breast ductal epithelium.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Discharge of cerebrospinal fluid through a hole through the skull bone most commonly draining from the nose (CEREBROSPINAL FLUID RHINORRHEA) or the ear (CEREBROSPINAL FLUID OTORRHEA).

The administration of nutrients for assimilation and utilization by a patient by means other than normal eating. It does not include FLUID THERAPY which normalizes body fluids to restore WATER-ELECTROLYTE BALANCE.

More From BioPortfolio on "The Effect of Crystalloids and Colloids on Visceral Blood Flow"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Renal disease
Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and might include feeling generally unwell and experi...


Searches Linking to this Trial