Effect Of Delta Sodium on the Postoperative Outcomes in L... | NCT04112004

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

NCT04112004

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Completed

Last Update Posted

Oct 2, 2019Actual

Enrollment

342Actual

Phase

Not provided

Conditions

Liver Transplant; Complications
Perioperative/Postoperative Complications
Electrolyte Disturbance

Interventions

Collecting sodium reports and outcome measures

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jun 30, 2019

First Submission Date that Met QC Criteria

Sep 29, 2019

First Posted Date

Oct 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2019

Last Update Posted Date

Oct 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karthik Ponnappan T, Consultant, Institute of Liver and Biliary Sciences, IndiaPrincipal Investigator

Lead Sponsor

Institute of Liver and Biliary Sciences, IndiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

342Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver Transplant Recipients		All elective liver transplant recipients done between study period	Other: Collecting sodium reports and outcome measures

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collecting sodium reports and outcome measures	Other		Liver Transplant Recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
post operative neurological complications	Post operative neurological complications after liver transplantation	1 month
duration of mechanical ventilation	duration of mechanical ventilation after liver transplantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karthik T Ponnappan, DM	Institute of Liver and Biliary Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver and Biliary Sciences		New Delhi	National Capital Territory of Delhi	110070	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 1, 2018	Sep 29, 2019	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017063	Outcome Assessment, Health Care

Ancestor Terms

ID	Term
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided