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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

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

Clinicaltrials.gov identifier NCT03933930

Recruitment Status Withdrawn (No patient wants to be recruited.)

First Posted May 1, 2019

Last update posted June 4, 2020

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.

  • Condition or Disease:Organ Failure, Multiple
  • Intervention/Treatment: Other: Lactate-directed therapy
    Other: Goal-directed therapy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
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
  • 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
  • Ages Eligible for Study: 20 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
Contacts
Locations
Sponsors and Collaborators

Taipei Medical University WanFang Hospital

More Information
  • Responsible Party: Taipei Medical University WanFang Hospital
  • ClinicalTrials.gov Identifier: NCT03933930 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Multiple Organ Failure