- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683614
Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to Reduce Renal Insult
June 17, 2022 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
Intraoperative Norepinephrine Versus Fresh Frozen Plasma in Patients Undergoing HIPEC to
comparing the effect of low dose norepinephrine infusion versus fresh frozen plasma in patients undergoing HIPEC to reduce renal insult
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11796
- Walaa Y Elsabeeny
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Fresh frozen plasma
early administration of fresh frozen plasma
|
early administration of fresh frozen plasma
Other Names:
|
EXPERIMENTAL: Low dose norepinephrine
low dose epinephrine 5 mic/kg/hr
|
5 mic/kg/hr norepinephrine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Renal insult
Time Frame: 24 hours
|
Creatinine level increase 0.3 mg/dl above preoperative baseline
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 20, 2020
Primary Completion (ACTUAL)
May 20, 2022
Study Completion (ACTUAL)
May 28, 2022
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (ACTUAL)
December 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 17, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201920025.2P
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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