跳至主要内容
临床试验/CTRI/2024/02/062479
CTRI/2024/02/062479招募中不适用

Prognostic value of prothrombin time - international normalised ratio to albumin ratio in patients with sepsis

Dr Sanchit Mittal1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
1
主要终点
To calculate the PT-INR to Albumin ratio in patients with sepsis and it’s prognostic efficiency in predicting patient outcome.

研究概览

简要总结

NEED FOR THE STUDY

Liver is a key integrator of microbial response and is a target organ during sepsis. An early and accurate assessment of liver function is critical in patients with sepsis and monitoring of hepatic dysfunction can serve as an independent predictor of mortality in sepsis. Several studies have shown that prothrombin time–international normalized ratio to albumin ratio showed good discrimination ability for predicting mortality and served as a convenient and practical tool for predicting prognosis of critically ill patients. Higher prothrombin time–international normalized ratio to albumin ratio are associated with greater risk for liver cirrhosis, post-operative liver failure and worse patient prognosis.

 DESCRIPTION

Patients will be selected based on the above inclusion exclusion criteria and recruited into the study after taking written informed consent. Prothrombin time–international normalized ratio to albumin ratio (PTAR Score) will be calculated and the patients will be divided into High, Intermediate and Low PTAR scores.

Data about the patient’s requirement for Mechanical Ventilation, Inotropic support and Hemodialysis will be collected.

Acute Physiology and Chronic Health Evaluation (APACHE II) Score will be calculated.

The collected data will be tabulated and analysed. The data will be recorded in MS Excel spreadsheet and statistics will be elaborated in the form of means/standard deviations and medians/IQRs for continuous variables, and frequencies and percentages for categorical variables.

Linear correlation between two continuous variables will be explored using Pearson’s correlation and Spearman’s correlation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted with the diagnosis of Sepsis in Kasturba Hospital, Manipal under the Department of General medicine 2) quick sequential organ failure assessment score (qSOFA) of 2 or more in patients with presumed infection will be used to define sepsis.

排除标准

  • Lack of PT-INR or albumin data within 24 hours of diagnosis of sepsis.
  • Pregnant patients 3) Patients with Malignancy 4) Patients on Anti coagulation therapy 5) Liver transplantation 6) Renal diseases like Nephrotic and Nephritic syndrome 7) Obstructive jaundice 8) Patients who have received Albumin or undergone plasmapheresis.

结局指标

主要结局

To calculate the PT-INR to Albumin ratio in patients with sepsis and it’s prognostic efficiency in predicting patient outcome.

时间窗: At the time of discharge or death

次要结局

  •  To correlate the PT-INR to Albumin ratio with requirement of Mechanical Ventilation, Hemodialysis and Inotropes.(During the hospital stay of patient)
  •  To compare the PT-INR to Albumin score with APACHE II score in predicting mortality in patients with sepsis(At the time of discharge or death)

研究者

发起方
Dr Sanchit Mittal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sanchit Mittal

Kasturba Medical College, MAHE, Manipal

研究点 (1)

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