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

NCT ID: NCT04683614

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-05-28

Brief Summary

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

Detailed Description

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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

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fresh frozen plasma

early administration of fresh frozen plasma

Group Type EXPERIMENTAL

Fresh frozen plasma

Intervention Type BIOLOGICAL

early administration of fresh frozen plasma

Low dose norepinephrine

low dose epinephrine 5 mic/kg/hr

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

5 mic/kg/hr norepinephrine

Interventions

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Norepinephrine

5 mic/kg/hr norepinephrine

Intervention Type DRUG

Fresh frozen plasma

early administration of fresh frozen plasma

Intervention Type BIOLOGICAL

Other Intervention Names

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low dose norepinephrine Blood products

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Walaa Youssef Elsabeeny

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Walaa Y Elsabeeny

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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201920025.2P

Identifier Type: -

Identifier Source: org_study_id

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