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临床试验/CTRI/2025/09/094573
CTRI/2025/09/094573尚未招募不适用

Association between Mean perfusion pressure and Acute kidney injury in Septic Shock: A Cohort Study

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月25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
200
试验地点
1
主要终点
Occurrence of AKI will be measured by Serum Creatinine levels and urine output as per KDIGO criteria for AKI

研究概览

简要总结

The study will be a prospective single- centre cohort study. The study will be carried out in ICUs of AIIMS New Delhi between August 2025- May 2027.

            The patients fulfilling inclusion and exclusion criteria will be recruited to the study. All the patients diagnosed to have sepsis with septic shock as per Sepsis-324 criteria will receive initial resuscitation as per Surviving Sepsis Campaign Guidelines with crystalloids 30ml/kg. If Mean Arterial Pressure (MAP) is less than 65mmHg, vasopressors are added as per SSC guidelines.21 All the patients will have an invasive arterial line for continuous invasive arterial blood pressure monitoring and a central venous catheter, continuous Central Venous Pressure is monitored. Rest of the management will be as per the treating physician’s decision.

At the admission to the ICU, demographic data like age, sex comorbidities will be collected Charlson comorbidity index will be calculated. Baseline Serum Creatinine, CVP, MAP and dose of vasopressors and inotropes are noted and Vasoactive inotrope score(VIS) will be calculated. Time to enrolment from diagnosis of sepsis will be noted. SOFA score and APACHE II scores will be calculated.

During the  ICU stay mean arterial pressure and central venous pressure will be noted every 6th hourly for the first 3 days. Hourly urine output will be noted. Ventilatory parameters like peak pressure, tidal volume, respiratory rate will be noted. Daily serum creatinine levels will be measured. Cumulative fluid balance and lactate levels will be noted for the first 3 days. Daily SOFA scores will be noted. Point of care ultrasound(POCUS) findings and intraabdominal pressure will be noted if available.

            Occurrence of AKI will be measured by Serum Creatinine levels and urine output as per KDIGO criteria for AKI 1. Other outcomes like duration of mechanical ventilation, length of ICU stay, requirement of RRT  and ICU mortality are noted.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18-75 years admitted to ICU with sepsis as per Sepsis-3 criteria and shock.

排除标准

  • Patient refusal to enroll to the study Pregnant patients Patients who are already a known case of CKD stage 3 and above Patient diagnosed with AKI stage 3 as per KDIGO criteria Patients with raised intra-abdominal pressure.

结局指标

主要结局

Occurrence of AKI will be measured by Serum Creatinine levels and urine output as per KDIGO criteria for AKI

时间窗: Hospital discharge or day 30 whichever is earlier

次要结局

  • Association between MPP & lactate clearance during(72hrs)
  • Association between MPP & cumulative fluid balance(day 3)
  • The trajectory of mean perfusion pressure with daily SOFA scores(day 3)
  • Association of MPP trajectory with mortality(day 30)
  • Association between trajectories of MPP & AKI(day 3)
  • Association between MPP & RRT free days(day 30)

研究者

发起方
AIIMS New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Kaushik D S

AIIMS New Delhi

研究点 (1)

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