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临床试验/CTRI/2025/11/097404
CTRI/2025/11/097404尚未招募不适用

Prevalence and association between acute kidney injury and central obesity among patients with sepsis admitted to the critical care units of a tertiary care hospital in Udupi, Karnataka.

Kasturba Hospital Manipal1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年12月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
1. Prevalence of acute kidney injury in sepsis patients

研究概览

简要总结

About 20% of patients admitted to the ICUs have obesity. Obesity, apart from its well-known cardio-vascular and metabolic adverse effects, also potentiates cytokine release, leading to a low-grade inflammatory state. Obesity has been associated with a higher risk of early SA-AKI, and studies have shown an association between obesity and the development of acute kidney injury (AKI) in patients with critical illness. Though obesity is known to be a risk factor for AKI and CKD, whether it specifically causes SA-AKI has not been extensively studied. Traditionally, the classification of obesity has been based on BMI. However, it is difficult to measure BMI in critically ill ICU patients to determine obesity class, as equipment to measure the weights in supine patients is often unavailable in resource-limited settings.The purpose of the study is to determine if central obesity (as assessed by B-mode ultrasound of intra-abdominal fat thickness and pre-peritoneal fat thickness) is associated with AKI in patients with sepsis. Investigating this association could reveal potential biomarkers or therapeutic targets to enhance patient outcomes in a critical care environment.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients aged above 18 years, 2 Patients of sepsis as diagnosed by the SOFA score based on Sepsis 3 criteria and having AKI based on KDIGO guideline criteria (SA-AKI).
  • 3 Admitted or transferred to ICUs.

排除标准

  • 1 Patients with a previously diagnosed chronic kidney disease (CKD) of any stage.
  • 2 Patients presenting with acute kidney injury (AKI) of more than 2 days’ duration (acute kidney disease, AKD), as the cause of AKD will be difficult to ascertain due to limitations in prospective follow-up.
  • 3 Discharge/death/transfer before 24 hrs of ICU admission.

结局指标

主要结局

1. Prevalence of acute kidney injury in sepsis patients

时间窗: Presence or absence of AKI - At baseline (during admission to the hospital) | If AKI is absent - assessment for development of AKI on 1st day of ICU admission, 3rd, and 5th day | Assessment for central obesity - 1st day of ICU admission

2. Proportion of patients with AKI developing non-resolving AKI and AKD.

时间窗: Presence or absence of AKI - At baseline (during admission to the hospital) | If AKI is absent - assessment for development of AKI on 1st day of ICU admission, 3rd, and 5th day | Assessment for central obesity - 1st day of ICU admission

3. Association between central obesity and development of AKI

时间窗: Presence or absence of AKI - At baseline (during admission to the hospital) | If AKI is absent - assessment for development of AKI on 1st day of ICU admission, 3rd, and 5th day | Assessment for central obesity - 1st day of ICU admission

次要结局

未报告次要终点

研究者

发起方
Kasturba Hospital Manipal
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sweekrity Benjamin

Manipal Academy of Higher Education, Manipal

研究点 (1)

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