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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
University Hospital Olomouc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acid Base Imbalance focused on measuring crystalloids, fluid therapy, Plasmalyte, Ringerfundin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 10, 2016
    Last Updated
    May 8, 2017
    Sponsor
    University Hospital Olomouc
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    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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