Clinical Trial: Perioperative Fluid Therapy With Balanced Crystalloids
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Perioperative Fluid Therapy With Balanced Crystalloids: a Comparative Randomized Prospective Open Label Study
Brief Summary:
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.
Detailed Summary:
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:
- 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
- Ringerfundin infusion solution (RF)
Sponsor: University Hospital Olomouc
Current Primary Outcome: 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.
Original Primary Outcome: 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 staus 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.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University Hospital Olomouc
Dates:
Date Received: February 10, 2016
Date Started: January 2014
Date Completion:
Last Updated: May 8, 2017
Last Verified: May 2017
