NCT04683614

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

December 21, 2020

Last Update Submit

June 17, 2022

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Renal insult

    Creatinine level increase 0.3 mg/dl above preoperative baseline

    24 hours

Study Arms (2)

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

NorepinephrineDRUG

5 mic/kg/hr norepinephrine

Also known as: low dose norepinephrine
Low dose norepinephrine
Fresh frozen plasmaBIOLOGICAL

early administration of fresh frozen plasma

Also known as: Blood products
Fresh frozen plasma

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Walaa Y Elsabeeny, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

October 20, 2020

Primary Completion

May 20, 2022

Study Completion

May 28, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

EG(1)