Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-80
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

Hepatobiliary and Pancreatic surgery is associated with substantial risk of postoperative complications. Albumin is a negative acute phase protein. Its rapid decline may be due to degree of inflammation due to surgical procedures. The decline may due to multifactorial causes. Currently, contemporary data regarding the time to recovery of albumin, as a marker for early recovery of patient from surgical stress is sparse. Delta albumin is influenced by perioperative fluid administration and albumin supplementation. Delta albumin may not reflect the true surgical stress. Early post op albumin is a reflection of intraoperative events and not postoperative recovery or events and is unpredictable. Shorter recovery time of albumin is associated with less post op complications and hospital stay. Earlier recovery of albumin predicts lower morbidity and shorter hospital stay.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients undergoing major Hepato pancreatico Biliary surgeries.

Patients who are more than 12 years of age

Retrospective arm - Data from 2010

Disqualifiers

Patients who refuse or are unable to give consent.

Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel

Disease, Chronic Liver Disease.

Emergency Surgeries

Trial population

All patients undergoing major Hepato pancreatico Biliary surgeries.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • NO TREATMENT

    Other intervention

    NO TREATMENT

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: hepatobiliary and pancreatic diseases1 intervention

Trial outcomes

Primary outcomes

1

Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay.

Time taken for unsupported albumin in Liver function test in a rising trend (g/dl)

Time frame
30 days

Secondary outcomes

1

To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay)

Major Complications measured by Clavien Dindo Classification (Major \>grade 3A) and Comprehensive complication index (Major More than 27)

Time frame
30 days
2

Time to reversal trend of albumin and Hospital stay

Time taken for unsupported albumin in Liver function test to reach a value of more than 3 g/dl and compared with the hospital stay

Time frame
30 days
3

correlation of time to recovery of albumin and re admission rates

Time taken for unsupported albumin in Liver function test to reach a value of more than 3 g/dl and compared with the 90 day re admission rates

Time frame
90 days

Other outcomes

Sponsors and contacts

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