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

Perioperative/Postoperative Complications Clinical Trial

— SOLT  

Official title:

Effect of Perioperative Delta Sodium on Outcomes in Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112004
• Other study ID #: ILBS - Liver Transplant-1
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Electrolyte Disturbance
• Liver Transplant; Complications
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• Collecting sodium reports and outcome measures

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in serum sodium in liver transplant recipients	difference between baseline and postoperative sodium in liver transplant recipients	1 day
Primary	post transplant mortality	post transplant mortality after liver transplantation	1 month
Secondary	post operative neurological complications	Post operative neurological complications after liver transplantation	1 month
Secondary	duration of mechanical ventilation	duration of mechanical ventilation after liver transplantation	1 month
Secondary	Duration of hospital stay	Hospital stay after liver transplantation	1 month
Secondary	Duration of ICU stay	Duration of ICU stay after liver transplantation	1 month