Perioperative Fluid Therapy With Balanced Crystalloids

May 8, 2017 updated by: Radovan Uvizl, University Hospital Olomouc

Perioperative Fluid Therapy With Balanced Crystalloids: a Comparative Randomized Prospective Open Label Study

Introduction: The strategy of perioperative fluid therapy has an important impact not only on the circulating volume and perfusion of organs and tissues but also on the patient's internal environment. The study aimed at comparing the effects of perioperatively administered balanced crystalloid infusion solutions containing different amounts of metabolizable anions on homeostasis.

Methods: In the prospective randomized study, patients were assigned to Plasmalyte (PL) and Ringerfundin (RF) Groups after their postoperative transfer to an intensive care unit (ICU). The infusion solutions were parenterally administered at 1000 mL/6 hours. Arterialized capillary blood was sampled at the time of transfer to the ICU (Time 0), and again at 2 hours and 6 hours from Time 0. The collected blood was tested for blood gas parameters using the Astrup method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design

The study was designed as a single-center, randomized, prospective study and approved by the University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc ethics committee. It comprised patients over 18 years of age undergoing surgery at the hospital's Department of Surgery I and subsequently placed in an ICU bed. As there were no limitations concerning the type of procedures, these involved a wide range of abdominal and thoracic surgeries; however, all of them were elective procedures. No patients were critically ill, being classified as ASA III or less.

Sample collection and processing To determine the present status of the internal environment, arterialized capillary blood was drawn from the fingertip at the time of patients' transfer from the operating room to the ICU (Time 0), and again at 2 hours and 6 hours from Time 0. The collected blood was tested in the laboratory using the Astrup method to measure the following parameters: pH, BE, actual bicarbonate (aBi), standard bicarbonate (sBi), partial pressure of oxygen (pO2) and carbon dioxide (pCO2). The obtained values were entered into a table and statistically analyzed. Both patients groups were adjusted for age and length of surgery to allow their comparison.

Infusion solutions

The following infusion solutions were parenterally administered using a central or, more frequently, peripheral venous catheter:

  1. Plasmalyte in 5% glucose infusion solution (PL), manufactured by Baxter Healthcare as slightly alkalizing (Na+ 140; K+ 5.0; Mg2+ 1.5; Cl- 98; acetate 27; gluconate 23) and
  2. Ringerfundin infusion solution (RF), manufactured by B. Braun as acid-base neutral (Na+ 145; K+ 4.0; Mg2+ 1.0; Ca2+ 2.5; Cl- 127; acetate 24; malate 5.0).

At the time of their transfer to the ICU, patients were randomized into PL and RF Groups. Parenteral administration of the two solutions was initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours. Patients requiring more rapid fluid replacement due to postoperative hypovolemia were excluded from the study. Patients were routinely rewarmed with a warm air blanket and received humidified oxygen via a face mask or, in case of good oxygenation, via a nasal cannula.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18+
  • elective surgery procedures

Exclusion Criteria:

  • critically ill, being classified as ASA III or less
  • surgery longer than 6 hrs
  • hypersensitivity to PL or RF
  • requiring more rapid fluid replacement (than 1000 ml/6 hrs) due to postoperative hypovolemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plasmalyte
Arm 1: Plasmalyte in 5% glucose infusion solution (PL), manufactured by Baxter Healthcare as slightly alkalizing (Na+ 140; K+ 5.0; Mg2+ 1.5; Cl- 98; acetate 27; gluconate 23)
Drug: Plasmalyte
Parenteral administration of Plasmalyte initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours.
Other Names:
  • Plasmalyte (Baxter Healthcare)
Active Comparator: Ringerfundin
Arm 2: Ringerfundin infusion solution (RF), manufactured by B. Braun as acid-base neutral (Na+ 145; K+ 4.0; Mg2+ 1.0; Ca2+ 2.5; Cl- 127; acetate 24; malate 5.0).
Drug: Ringerfundin
Parenteral administration of Ringerfundin initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours.
Other Names:
  • Ringerfundin (B. Braun)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with significant acid basic disturbances related to balanced alkalizing as compared with a balanced pH-neutral crystalloids.
Time Frame: 6 hours
The internal environment status is assessed at the time of patients' transfer from the operating room to the ICU (Time 0), and again at 6 hours from Time 0. Outcome over a longer period of time is not rated.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Olomouc

Investigators

  • Principal Investigator: Radovan Uvizl, University Hospital Olomouc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 20, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV29125 16/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acid Base Imbalance

Clinical Trials on Plasmalyte

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe