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出境医 / 临床实验 / Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.

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

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 Not Applicable

Study Design
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
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
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
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date June 4, 2020
Estimated Study Start Date  ICMJE May 6, 2019
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
Official Title  ICMJE Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Organ Failure, Multiple
Intervention  ICMJE
  • 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%.
Study Arms  ICMJE
  • Experimental: Lactate-directed therapy
    Interventions:
    • Other: Lactate-directed therapy
    • Other: Goal-directed therapy
  • Experimental: Goal-directed therapy
    Intervention: Other: Goal-directed therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 31, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2019) 		60
Estimated Study Completion Date  ICMJE May 15, 2021
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients receiving hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

  • Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933930
Other Study ID Numbers  ICMJE N201803039
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party anchihhsu, Taipei Medical University WanFang Hospital
Study Sponsor  ICMJE Taipei Medical University WanFang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taipei Medical University WanFang Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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