跳至主要内容
临床试验/NCT07263061
NCT07263061招募中不适用

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

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年12月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Time to recovery of serum albumin as a predictor of outcome in major hepatobiliary surgeries as measured by hospital stay.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
13 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing major Hepato pancreatico Biliary surgeries.
  • Patients who are more than 12 years of age
  • Retrospective arm - Data from 2010

排除标准

  • Patients who refuse or are unable to give consent.
  • Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel
  • Disease, Chronic Liver Disease.
  • Emergency Surgeries

结局指标

主要结局

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

时间窗: 30 days

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

次要结局

  • To correlate the time to recovery of albumin with complications and morbidity (Clavien Dindo classification, Comprehensive Complication Index, Intensive Care Unit Stay)(30 days)
  • Time to reversal trend of albumin and Hospital stay(30 days)
  • correlation of time to recovery of albumin and re admission rates(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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