Perioperative Fluid Therapy With Balanced Crystalloids
Primary Purpose
Acid Base Imbalance
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Plasmalyte
Ringerfundin
Sponsored by
About this trial
This is an interventional treatment trial for Acid Base Imbalance focused on measuring crystalloids, fluid therapy, Plasmalyte, Ringerfundin
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Plasmalyte
Ringerfundin
Arm Description
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)
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).
Outcomes
Primary Outcome Measures
Number of participants with significant acid basic disturbances related to balanced alkalizing as compared with a balanced pH-neutral crystalloids.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02691676
First Posted
February 10, 2016
Last Updated
May 8, 2017
Sponsor
University Hospital Olomouc
1. Study Identification
Unique Protocol Identification Number
NCT02691676
Brief Title
Perioperative Fluid Therapy With Balanced Crystalloids
Official Title
Perioperative Fluid Therapy With Balanced Crystalloids: a Comparative Randomized Prospective Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Olomouc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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:
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), 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acid Base Imbalance
Keywords
crystalloids, fluid therapy, Plasmalyte, Ringerfundin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasmalyte
Arm Type
Experimental
Arm Description
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)
Arm Title
Ringerfundin
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Plasmalyte
Other Intervention Name(s)
Plasmalyte (Baxter Healthcare)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ringerfundin
Other Intervention Name(s)
Ringerfundin (B. Braun)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with significant acid basic disturbances related to balanced alkalizing as compared with a balanced pH-neutral crystalloids.
Description
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.
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radovan Uvizl
Organizational Affiliation
University Hospital Olomouc
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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21171525
Citation
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Perioperative Fluid Therapy With Balanced Crystalloids
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