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SepsisNCT05109156

Preoperative Sepsis Timeline, Profile and Its Association With Recipient Outcome Following Live Donor Liver Transplant

An observational study of Sepsis and Liver Transplant; Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Preoperative sepsis timeline, profile and its association with recipient outcome following live donor liver transplant. Read more about this study

Who is it for?
Ages Up to 70 years
Conditions the study is for
Sepsis, Liver Transplant; Complications
What is being tested?
This is an observational study
How many people
500 participants
Where
1 siteIndia
Study dates
5 Nov 2021to Apr 2022
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 Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients undergoing/ undergone live donor liver transplant at our institute

Inclusion Criteria:All patients who undergo living donor liver transplant.

-

Exclusion Criteria: Acute Liver Failure

Trial locations and contacts

1 site in 1 country.

Bharat Nair, MBBS, MS,MRCS contact

+91-8373926785

bharatarcher1@gmail.com

India1 site, 1 recruiting
  • Institute of Liver and Biliary Sciences

    New Delhi, National Capital Territory of Delhi, 110070

    Bharat Nair, MBBS,MS,MRCS, +91-8373926785, bharatarcher1@gmail.com

    Ankit

    Recruiting

Other trials in India

About this study

Preoperative sepsis timeline, profile and its association with recipient outcome following live donor liver transplant.

Read the detailed description

Sepsis is a critical factor causing major mortality and morbidity in liver recipients.

  • According to guidelines patients with active infection should be treated before listing, and those who develop infection while on the waiting list should be removed until the infection is cured or has improved with appropriate antimicrobial treatment.
  • Live donor liver transplant (LDLT) in comparison to Deceased Donor Liver Transplant (DDLT) is a more planned surgery. This gives us an opportunity for preoperative optimization and surgery can be timed. In identifying the impact of timing of LDLT wrt. sepsis , major morbidity can be reduced by optimizing/delaying timing of transplant. On the other hand, preoperative optimization may not be as critical as currently thought, and many more patients , currently delisted following sepsis can reap the benefits of a timely transplant. Results will help in better selection of patients as well as better management of pre transplant sepsis. A variety of studies have evaluated the impact of preoperative sepsis at different periods prior to LT on postoperative outcomes but results are widely varied.

The subsets of macrophages in hepatic capsule are known as liver capsular macrophages(LCMs). LCMs recruit neutrophils in response to bacteria reaching the liver capsule .LCM depletion increases liver pathogen load. Further it is also important to study peritoneal macrophages in chronic liver disease . Chronic sterile inflammation, as in nonalcoholic fatty liver disease, is associated with constant release of damage-associated molecular patterns. Continuous activation and recruitment of peritoneal and Liver capsular macrophages may contribute to fibrogenesis under condition of chronic liver diseases. Study of LCMs and PMs could be a landmark study identifying peritoneal macrophages and Liver capsular macrophages as highly mobile cells with a specialized function , with many possible therapeutic applications.The study will be collecting data both prospectively and retrospectively and will involve assessment of association of timeline and profile of preoperative sepsis on mortality and morbidity of liver transplant recipients. Primary objective will be Correlation of timeline of sepsis with recipient outcome following Live donor liver transplant. Outcome parameters will be Post operative sepsis ,In hospital mortality, Hospital stay, ICU stay, Retransfer to ICU, Days on ventilator, Need for tracheostomy/re-intubation, Duration of inotropic support. Secondary objectives To study the impact of source of sepsis on postoperative outcomes, To evaluate the causative organism of sepsis on post operative outcome. To study the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome. 25 samples will be collected for liver capsular and peritoneal macrophage study.

Being tested
This is an observational study
Keywords
Sepsis, Live donor liver transplant(LDLT),, Liver capsular macrophages(LCM), Peritoneal macrophages(PM)
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • This is an observational studyOther

    This is an observational study

Study groups in NCT05109156
Study groupRoleWhat they receive
This is an observational studyThis is an observational study
Receives: Other: This is an observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of timeline of sepsis with recipient outcome following Live donor liver transplant.

    1. Post-operative sepsis b. In hospital mortality c. Hospital stay d. ICU stay e. Retransfer to ICU f. Days on ventilator g. Need for tracheostomy/re-intubation h Duration of inotropic support

    Measured: 30 days

Secondary outcomes (1)
  1. study the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome.

    study the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2021
  2. Study start5 Nov 2021
  3. Primary completionFeb 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

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
Case only
Time perspective
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05109156
Sponsor's protocol ID
ILBS-Sepsis-02
Status last verified
Oct 2021
First submitted
20 Oct 2021
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nair B, Mohapatra N, Patil NS, Reddy HVG, Sindwani G, Khillan V, Sarin SK, Pamecha V. Preoperative Infection Within a Month is Associated With Inferior Posttransplant Outcomes in Adult Living Donor Liver Transplants. J Clin Exp Hepatol. 2026 Mar-Apr;16(2):103469. doi: 10.1016/j.jceh.2026.103469. Epub 2026 Jan 19.

    PubMed 41732373

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Liver Transplant; 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?

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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bharat Nair, MBBS, MS,MRCS (+91-8373926785, bharatarcher1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of timeline of sepsis with recipient outcome following Live donor liver transplant. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05109156, which also lists 1 linked publication.

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 26 Jan 2022.

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