Liver Transplant; ComplicationsSOLTNCT04112004
Effect Of Delta Sodium on the Postoperative Outcomes in Liver Transplant Recipients
An observational study of Liver Transplant; Complications and Perioperative/Postoperative Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications, Perioperative/Postoperative Complications, Electrolyte Disturbance
- What is being tested?
- Collecting sodium reports and outcome measures
- How many people
- 342 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2011to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant recipients more than 18 years in ILBS during study period
Who may be able to join
- All liver transplant recipients between Jan 2011 to Jan 2017
- Records available
Who cannot join
- Acute fulminant liver failure
- All patients less than 18 years
- Re operated cases
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplant; Complications, Perioperative/Postoperative Complications, Electrolyte Disturbance
- Being tested
- Collecting sodium reports and outcome measures
- Keywords
- liver transplantation, perioperative sodium, sodium
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting sodium reports and outcome measuresOther
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant Recipients | All elective liver transplant recipients done between study period Receives: Other: Collecting sodium reports and outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum sodium in liver transplant recipients
difference between baseline and postoperative sodium in liver transplant recipients
Measured: 1 day
post transplant mortality
post transplant mortality after liver transplantation
Measured: 1 month
Secondary outcomes (4)
post operative neurological complications
Post operative neurological complications after liver transplantation
Measured: 1 month
duration of mechanical ventilation
duration of mechanical ventilation after liver transplantation
Measured: 1 month
Duration of hospital stay
Hospital stay after liver transplantation
Measured: 1 month
Duration of ICU stay
Duration of ICU stay after liver transplantation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Jan 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Ponnappan T, Institute of Liver and Biliary Sciences, India
- Investigators
- Karthik T Ponnappan, DM, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112004
- Sponsor's protocol ID
- ILBS - Liver Transplant-1
- Acronym
- SOLT
- Status last verified
- Sep 2019
- First submitted
- 30 Jun 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Delta Sodium on Outcomes in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT04112004
- Acronym / sponsor ID
- SOLT / ILBS - Liver Transplant-1
- Conditions
- Liver Transplant; Complications, Perioperative/Postoperative Complications, Electrolyte Disturbance
- Keywords
- liver transplantation, perioperative sodium, sodium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant Recipients | – | Other: Collecting sodium reports and outcome measuresAll elective liver transplant recipients done between study period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant recipients more than 18 years in ILBS during study period
Key inclusion criteria (2 listed)
- All liver transplant recipients between Jan 2011 to Jan 2017
- Records available
Key exclusion criteria (4 listed)
- Acute fulminant liver failure
- All patients less than 18 years
- Re operated cases
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting sodium reports and outcome measures | Other | Liver Transplant Recipients |
Primary outcome
change in serum sodium in liver transplant recipients
Time frame: 1 day
difference between baseline and postoperative sodium in liver transplant recipients
post transplant mortality
Time frame: 1 month
post transplant mortality after liver transplantation
4 secondary outcomes
post operative neurological complications
Time frame: 1 month
duration of mechanical ventilation
Time frame: 1 month
Duration of hospital stay
Time frame: 1 month
Duration of ICU stay
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karthik T Ponnappan, DM principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Perioperative/Postoperative Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in serum sodium in liver transplant recipients (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.