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Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.

Primary Purpose

Organ Failure, Multiple

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactate-directed therapy
Goal-directed therapy
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Organ Failure, Multiple

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients receiving hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

  • Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Lactate-directed therapy

    Goal-directed therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    pulmonary complication
    X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support

    Secondary Outcome Measures

    Renal complication
    oliguria with urine output<0.5 ml/kg/h for more than 4 h, creatinine increase>30 % of preoperative values, dialysis

    Full Information

    First Posted
    April 12, 2019
    Last Updated
    May 31, 2020
    Sponsor
    Taipei Medical University WanFang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03933930
    Brief Title
    Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
    Official Title
    Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No patient wants to be recruited.
    Study Start Date
    May 6, 2019 (Anticipated)
    Primary Completion Date
    May 15, 2021 (Anticipated)
    Study Completion Date
    May 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University WanFang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. We expect to confirm the better prognosis of lactate-directed therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Organ Failure, Multiple

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lactate-directed therapy
    Arm Type
    Experimental
    Arm Title
    Goal-directed therapy
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Lactate-directed therapy
    Intervention Description
    If the lactate level elevates, we transfuse pRBC to increase Hct>30%. If Hct >30%, dopamine infusion starts.
    Intervention Type
    Other
    Intervention Name(s)
    Goal-directed therapy
    Intervention Description
    If SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%.
    Primary Outcome Measure Information:
    Title
    pulmonary complication
    Description
    X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Renal complication
    Description
    oliguria with urine output<0.5 ml/kg/h for more than 4 h, creatinine increase>30 % of preoperative values, dialysis
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients receiving hyperthermic intraperitoneal chemotherapy Exclusion Criteria: Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.

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