A randomised control trial to evaluate renal oxygen saturation as a guide to altered renal perfusion in adult cardiac surgery patients.

AIIMS Rishikesh1 个研究点分布在 1 个国家目标入组 88 人开始时间: 2020年10月29日最近更新: 2020年10月28日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: AIIMS Rishikesh
入组人数: 88
试验地点: 1
主要终点: To assess the efficacy of intervention based on renal rSO2 monitoring in prevention of AKI in post operative period in elective adult cardiac surgical patients

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Hypothesis of this study is that intraoperative monitoring of renal rSO2 withmeasures to minimise the decline from baseline rSO2, would result in lesser risein serum creatinine values in the postoperative period for elective cardiacsurgical patients, undergoing CABG, valve surgery or combined surgeries.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Patients in the age group of 18 to 60 years of age, of either sex ASA II.
•III patients Patients posted for elective cardiac surgery including CABG, valve surgery, combined CABG and valve surgery, under cardiopulmonary bypass Patients willing to give informed and written consent.

排除标准

•Patients refusal Emergency surgery Aortic surgery Preoperative renal dysfunction, defined as S.Cr > 1.5mg/dl or end-stage renal disease Preoperative low cardiac output state, defined as Left Ventricle Ejection Fraction ( LVEF ) < 30% Body Mass Index ( BMI ) > 30kg/m2 Post renal transplant status Off pump coronary artery bypass grafting surgery Skin to renal capsule distance > 40 mm.

结局指标

主要结局

To assess the efficacy of intervention based on renal rSO2 monitoring in prevention of AKI in post operative period in elective adult cardiac surgical patients

时间窗: renal saturation monitoring will be done intraoperatively and efficacy of the intervention will be assessed by measuring serum creatinine postoperatively for 2 days

次要结局

1.To assess the change in renal rSO2 during intra-operative period as predictor of change in serum creatinine in post-operative period in elective adult cardiac surgical patients.(2.To determine the change in eGFR)

研究者

发起方

AIIMS Rishikesh

申办方类型

Research institution and hospital

研究点 (1)

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