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

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ClinicalTrials.gov Identifier: NCT03933930
Recruitment Status : Withdrawn (No patient wants to be recruited.)
First Posted : May 1, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
anchihhsu, Taipei Medical University WanFang Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Organ Failure, Multiple Other: Lactate-directed therapy Other: Goal-directed therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
Estimated Study Start Date : May 6, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lactate-directed therapy Other: Lactate-directed therapy
If the lactate level elevates, we transfuse pRBC to increase Hct>30%. If Hct >30%, dopamine infusion starts.

Other: Goal-directed therapy
If SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%.
Experimental: Goal-directed therapy Other: Goal-directed therapy
If SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%.


Outcome Measures
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Primary Outcome Measures :
  1. pulmonary complication [ Time Frame: 1 week ]
    X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support


Secondary Outcome Measures :
  1. Renal complication [ Time Frame: 1 week ]
    oliguria with urine output<0.5 ml/kg/h for more than 4 h, creatinine increase>30 % of preoperative values, dialysis


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: anchihhsu, Principal Investigator, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03933930    
Other Study ID Numbers: N201803039
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Organ Failure
Shock
Pathologic Processes