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Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to Reduce Renal Insult

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT04683614
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
19.2
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

comparing the effect of low dose norepinephrine infusion versus fresh frozen plasma in patients undergoing HIPEC to reduce renal insult

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

To compare the efficacy of maintaining intraoperative hemodynamic stability through infusing low dose norepinephrine versus fresh frozen plasma in patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy in cancer patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to
Actual Study Start Date :
Oct 20, 2020
Actual Primary Completion Date :
May 20, 2022
Actual Study Completion Date :
May 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fresh frozen plasma

early administration of fresh frozen plasma

Biological: Fresh frozen plasma
early administration of fresh frozen plasma
Other Names:
  • Blood products

    		•
    Experimental: Low dose norepinephrine

    low dose epinephrine 5 mic/kg/hr

    Drug: Norepinephrine
    5 mic/kg/hr norepinephrine
    Other Names:
  • low dose norepinephrine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Renal insult [24 hours]

      Creatinine level increase 0.3 mg/dl above preoperative baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA I and II

    • World Health Performance Status ≤2

    • scheduled for CRS/HIPEC operations

    Exclusion Criteria:

    • patient's refusal

    • allergy to any of the used drugs

    • impaired renal or liver functions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walaa Y Elsabeeny Cairo Egypt 11796

    Sponsors and Collaborators

    • National Cancer Institute, Egypt

    Investigators

    • Principal Investigator: Walaa Y Elsabeeny, MD, Lecturer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walaa Youssef Elsabeeny, Principal Investigator, National Cancer Institute, Egypt
    ClinicalTrials.gov Identifier:
    NCT04683614
    Other Study ID Numbers:
    • 201920025.2P
    First Posted:
    Dec 24, 2020
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Norepinephrine

    Study Results

    No Results Posted as of Jun 21, 2022