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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Biological: Fresh frozen plasma; Drug: Norepinephrine

• Registration Number: NCT04683614
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

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

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 Timeline

• Study Start: 2020-10-20
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresh frozen plasma	Fresh frozen plasma	early administration of fresh frozen plasma
Low dose norepinephrine	Norepinephrine	low dose epinephrine 5 mic/kg/hr

Primary Outcome Measures

Name	Time	Method
Renal insult	24 hours	Creatinine level increase 0.3 mg/dl above preoperative baseline

Trial Locations

Locations (1)

Walaa Y Elsabeeny; 🇪🇬 Cairo, Egypt