NCT04112004

Brief Summary

We analyzed the association of delta sodium levels with their effect on post liver transplant outcomes in consecutive patients undergoing liver transplantation. Records were analyzed for electrolytes and outcome measures, and data was analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

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

January 1, 2011

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

7 years

First QC Date

June 30, 2019

Last Update Submit

September 29, 2019

Conditions

Liver Transplant; ComplicationsPerioperative/Postoperative ComplicationsElectrolyte Disturbance

Keywords

liver transplantationperioperative sodiumsodium

Outcome Measures

Primary Outcomes (2)

  • change in serum sodium in liver transplant recipients

    difference between baseline and postoperative sodium in liver transplant recipients

    1 day

  • post transplant mortality

    post transplant mortality after liver transplantation

    1 month

Secondary Outcomes (4)

  • post operative neurological complications

    1 month

  • duration of mechanical ventilation

    1 month

  • Duration of hospital stay

    1 month

  • Duration of ICU stay

    1 month

Study Arms (1)

Liver Transplant Recipients

All elective liver transplant recipients done between study period

Other: Collecting sodium reports and outcome measures

Interventions

Collecting sodium reports and outcome measuresOTHER
Liver Transplant Recipients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Liver transplant recipients more than 18 years in ILBS during study period

You may qualify if:

  • All liver transplant recipients between Jan 2011 to Jan 2017
  • Records available

You may not qualify if:

  • Acute fulminant liver failure
  • All patients less than 18 years
  • Re operated cases
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Karthik T Ponnappan, DM

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

June 30, 2019

First Posted

October 2, 2019

Study Start

January 1, 2011

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

October 2, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)