Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (No patient wants to be recruited.)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

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

Layout table for study information
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

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%.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for additonal information
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

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