NCT02544919

Brief Summary

To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

September 7, 2015

Last Update Submit

March 24, 2017

Conditions

Neurological Complications

Keywords

SMOFneurological complicationsneurotoxicityliver transplantationLipid emulsions

Outcome Measures

Primary Outcomes (1)

  • post-transplant neurological complications

    Number of participants who develop neurological complications

    5 post-operative days

Secondary Outcomes (2)

  • Graft functions

    5 post-operative days

  • survival

    30 days

Study Arms (2)

Control group

NO INTERVENTION

No Intervention group: Patients do not receive any lipid emulsion of any type during the study period

SMOF Group

ACTIVE COMPARATOR

Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively.

Drug: SMOF lipid (SMOFLIPID) pre treatment

Interventions

SMOF lipid (SMOFLIPID) pre treatmentDRUG

Experimental Arm

Also known as: Experimental group
SMOF Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult living donor liver transplant recipients of either sex

You may not qualify if:

  • MELD score \> 30
  • Retransplantation
  • Budd Chiari syndrome
  • Diabetes more than 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver transplantation project - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Neurotoxicity Syndromes

Interventions

SMOFlipid

Condition Hierarchy (Ancestors)

Nervous System DiseasesPoisoningChemically-Induced Disorders

Study Officials

  • Amr M Yassen, MD

    MAnsoura Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr M. Yassen, MD

CONTACT

01001497044amryassen@hotmail.com

waleed R Elsarraf, MD

CONTACT

welsarraf@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive care

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

March 27, 2017

Record last verified: 2016-07

Locations

EG(1)