NCT02691676

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

Completed Phase 3 Last updated 8 May 2017

What this trial tests

Phase 3 trial testing Plasmalyte in Acid Base Imbalance in 112 participants. Completed in 1 December 2014.

Timeline

1 January 2014

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	University Hospital Olomouc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	1 January 2014
Primary completion	1 December 2014
Estimated completion	1 December 2014

Drugs / interventions tested

• Plasmalyte — full drug profile →
• Ringerfundin — full drug profile →

Conditions studied

• Acid Base Imbalance — all drugs for Acid Base Imbalance →

Sponsor

University Hospital Olomouc

Who can join

18 and older, any sex, with Acid Base Imbalance. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.