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临床试验/CTRI/2025/11/097097
CTRI/2025/11/097097尚未招募不适用

Incidence and Long term impact of postoperative Acute Kidney Injury in patients undergoing major abdominal surgery (IMPACT PO-AKI)

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
174
试验地点
1
主要终点
Incidence of PO-AKI (an acute alteration in kidney function) within 7 days in patients undergoing major abdominal surgery including, Hepatic resection, Pancreatic surgery, cytoreductive surgery with or without HIPEC

研究概览

简要总结

Postoperative acute kidney injury (PO-AKI) is a common complication of major surgery  that is strongly associated with short-term surgical complications and long-term adverse outcomes,  including increased risk of chronic kidney disease  cardiovascular events and death.POAKI is best defined as AKI occurring within 7 days of an operative intervention using  the Kidney Disease Improving Global Outcomes (KDIGO) definition of AKI. Prevention of PO-AKI is  largely based on identification of high baseline risk, monitoring and reduction of nephrotoxic insults,  whereas treatment involves the application of a bundle of interventions to avoid secondary kidney  injury and mitigate the severity of AKI.

Acute Kidney injury (AKI) is described as an abrupt and reversible decline in the glomerular filtration  rate (GFR) which results in an elevation of serum blood urea nitrogen (BUN), creatinine and other  metabolic waste products that are normally excreted by the kidney. In 2012, Kidney Disease  Improving Global Outcomes (KDIGO) described the KDIGO AKI diagnostic criteria and categorized AKI  into stages 1–3, determined by changes in serum creatinine and/or urine output.

The risk of developing AKI following emergency  major abdominal surgery is 17percent. The risk of renal injury is particularly high in patients treated with cisplatin-containing HIPEC regimens . Incidence of AKI in  patients undergoing laparoscopic pancreas surgeries was 11percent . Incidence of PO-AKI in TMH patients undergoing major abdominal cancer surgery was 10percent. Colloids have been associated with acute kidney injury. Recently, there has been a change in departmental fluid policy i.e. no use of colloids in the perioperative period, therefore we planned this prospective observational study was to study the incidence of PO-AKI.

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

  • Consenting patients more than 18 years of age, undergoing elective major abdominal surgeries including Liver, pancreatic, cytoreductive surgery with or without HIPEC.
  • Patients undergoing open, laparoscopic, laparoscopic-assisted, laparoscopic converted and robotic procedures.

排除标准

  • Patients not willing to consent
  • Patients undergoing surgical procedures other than those mentioned above
  • Patients undergoing planned or unplanned nephrectomy
  • Patients with pre-existing renal disease (previous history of AKI according to KDIGO criteria)
  • Post kidney transplant patient
  • Patients with end stage kidney disease on dialysis.
  • Renal replacement therapy (any form of dialysis) within the 90 days preceding the operation.

结局指标

主要结局

Incidence of PO-AKI (an acute alteration in kidney function) within 7 days in patients undergoing major abdominal surgery including, Hepatic resection, Pancreatic surgery, cytoreductive surgery with or without HIPEC

时间窗: Within first 7 days after surgery

次要结局

  • 1. Incidence of Early PO-AKI ( AKI occurring within 48 hrs after surgery)(2. Incidence of AKD (a sustained alteration in kidney function over a 3-month period i.e. persisting after 7 days until 3 months after surgery))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vandana Agarwal

Tata Memorial Hospital

研究点 (1)

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