NCT04376281

Brief Summary

Early administration of NE in liver transplant recipient might enhance cardiac output through an increase in cardiac preload .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

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

December 15, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

April 15, 2020

Last Update Submit

November 8, 2021

Conditions

Keywords

Liver transplantaion , fluid management , noradrenaline

Outcome Measures

Primary Outcomes (1)

  • The effect of Noradrenaline on change of cardiac output .

    The effect of Noradrenaline on change of cardiac output .

    along the procedure ; from skin incision to the end of surgery

Secondary Outcomes (3)

  • The effect of NE on mean systemic filling pressure .

    along the procedure ; from skin incision to the end of surgery

  • The effect of NE on venous return .

    along the procedure ; from skin incision to the end of surgery

  • The effect of NE on central venous pressure .

    along the procedure ; from skin incision to the end of surgery

Study Arms (1)

Noradrenaline group

EXPERIMENTAL
Drug: Noradrenaline

Interventions

Noradrenaline infusion for patients undergoing liver transplantaion from living donor .

Noradrenaline group

Eligibility Criteria

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

You may not qualify if:

  • Patients less than 18 years.
  • Patients undergoing liver transplantation for acute liver failure .
  • All Chronic Hypertensive patients on medication , whether controlled on not controlled
  • Those with high risk of post transplant renal dysfunction (serum creatinine \>1.5 mg/dL at time of transplant)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr El Ainy school of medicine

Cairo, 11211, Egypt

Location

Related Publications (4)

  • Rudnick MR, Marchi LD, Plotkin JS. Hemodynamic monitoring during liver transplantation: A state of the art review. World J Hepatol. 2015 Jun 8;7(10):1302-11. doi: 10.4254/wjh.v7.i10.1302.

    PMID: 26052376BACKGROUND
  • Moller S, Bendtsen F, Henriksen JH. Effect of volume expansion on systemic hemodynamics and central and arterial blood volume in cirrhosis. Gastroenterology. 1995 Dec;109(6):1917-25. doi: 10.1016/0016-5085(95)90759-9.

    PMID: 7498657BACKGROUND
  • Mukhtar A, Dabbous H. Modulation of splanchnic circulation: Role in perioperative management of liver transplant patients. World J Gastroenterol. 2016 Jan 28;22(4):1582-92. doi: 10.3748/wjg.v22.i4.1582.

    PMID: 26819524BACKGROUND
  • Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.

    PMID: 19237896BACKGROUND

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ahmed M Mukhtar, MD

    professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 15, 2020

First Posted

May 6, 2020

Study Start

December 15, 2019

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations