Effect Of Delta Sodium on the Postoperative Outcomes in Liver Transplant Recipients (SOLT)

September 29, 2019 updated by: Karthik Ponnappan T, Institute of Liver and Biliary Sciences, India

Effect of Perioperative Delta Sodium on Outcomes in Liver Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preoperative hyponatremia was identified in patients. The mean change in sodium in hyponatremic patients was compared with inpatients with normal sodium levels. The impact of the delta sodium levels with short-term outcomes, such as duration of intubation, intensive care unit length of stay were analyzed with univariate and multivariate logistic regression analyses.

Study Type

Observational

Enrollment (Actual)

342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver Transplant Recipients
All elective liver transplant recipients done between study period
Other: Collecting sodium reports and outcome measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in serum sodium in liver transplant recipients
Time Frame: 1 day
difference between baseline and postoperative sodium in liver transplant recipients
1 day
post transplant mortality
Time Frame: 1 month
post transplant mortality after liver transplantation
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative neurological complications
Time Frame: 1 month
Post operative neurological complications after liver transplantation
1 month
duration of mechanical ventilation
Time Frame: 1 month
duration of mechanical ventilation after liver transplantation
1 month
Duration of hospital stay
Time Frame: 1 month
Hospital stay after liver transplantation
1 month
Duration of ICU stay
Time Frame: 1 month
Duration of ICU stay after liver transplantation
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Karthik T Ponnappan, DM, Institute of Liver and Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

June 30, 2019

First Submitted That Met QC Criteria

September 29, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 29, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS - Liver Transplant-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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