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

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03933930

Collaborator

(none)

Enrollment

Arms

24.3

Anticipated Duration (Months)

Study Details

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	Intervention/Treatment	Phase
Organ Failure, Multiple	Other: Lactate-directed therapy Other: Goal-directed therapy	N/A

Study Design

Study Type:

Interventional

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.

Anticipated Study Start Date :

May 6, 2019

Anticipated Primary Completion Date :

May 15, 2021

Anticipated Study Completion Date :

May 15, 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%.

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

pulmonary complication [1 week]
X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support

Secondary Outcome Measures

Renal complication [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

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taipei Medical University WanFang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

anchihhsu, Principal Investigator, Taipei Medical University WanFang Hospital

ClinicalTrials.gov Identifier:

NCT03933930

Other Study ID Numbers:

N201803039

First Posted:

May 1, 2019

Last Update Posted:

Jun 4, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Organ Failure

Study Results

No Results Posted as of Jun 4, 2020