Intraoperative Norepinephrine Versus Fresh Frozen Plasma... | NCT04683614

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

NCT04683614

Sponsor

National Cancer Institute, Egypt

Status

Completed

Last Update Posted

Jun 21, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Norepinephrine
Fresh frozen plasma

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2020Actual

Primary Completion Date

May 20, 2022Actual

Completion Date

May 28, 2022Actual

First Submitted Date

Dec 21, 2020

First Submission Date that Met QC Criteria

Dec 21, 2020

First Posted Date

Dec 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2022

Last Update Posted Date

Jun 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walaa Youssef Elsabeeny, Principal Investigator, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Norepinephrine	Drug	5 mic/kg/hr norepinephrine	Low dose norepinephrine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal insult	Creatinine level increase 0.3 mg/dl above preoperative baseline	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walaa Y Elsabeeny, MD	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walaa Y Elsabeeny		Cairo		11796	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D009638	Norepinephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

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Browse Branches

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