CompletedNCT04683614Updated Jun 21, 2022

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

An interventional study of Norepinephrine and Fresh frozen plasma in Anesthesia, sponsored by National Cancer Institute, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Read the 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

Conditions studied

Anesthesia

In context

Lead sponsor

National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

ASA I and II
World Health Performance Status ≤2
scheduled for CRS/HIPEC operations

Exclusion criteria

Exclusion Criteria:

patient's refusal
allergy to any of the used drugs
impaired renal or liver functions

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Experimental
Fresh frozen plasma
early administration of fresh frozen plasma
Biological: Fresh frozen plasma
Experimental
Low dose norepinephrine
low dose epinephrine 5 mic/kg/hr
Drug: Norepinephrine

Interventions

DrugNorepinephrine
5 mic/kg/hr norepinephrine
Also known as: low dose norepinephrine
BiologicalFresh frozen plasma
early administration of fresh frozen plasma
Also known as: Blood products

What researchers measure

Primary outcomes

Renal insult
Creatinine level increase 0.3 mg/dl above preoperative baseline
Time frame: 24 hours

Study locations

1 site

Walaa Y Elsabeeny
Cairo, 11796, Egypt

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04683614
Lead sponsor: National Cancer Institute, Egypt
Responsible party: Walaa Youssef Elsabeeny (Principal Investigator, National Cancer Institute, Egypt) — Principal investigator
First posted: Dec 24, 2020
Start date: Oct 20, 2020
Primary completion: May 20, 2022
Completion: May 28, 2022
Last update: Jun 21, 2022

Study contacts

Walaa Y Elsabeeny, MD

principal investigator · Lecturer

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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