Prevention of Postoperative Acute Kidney Injury

Not Applicable

Withdrawn

• Conditions: Acute Kidney Injury
• Interventions: Procedure: kidney treatment bundle (KDIGO)

• Registration Number: NCT02583945
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.

Detailed Description

All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.

Study Timeline

• Study First Submitted: 2015-09-23
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Primary Completion: 2016-10
• Study Completion: 2017-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kidney treatment bundle (KDIGO)	kidney treatment bundle (KDIGO)	Consequent postoperative application of a kidney treatment bundle: Protocol based hemodynamic optimization and monitoring, regular screening of creatinine in serum and of urine output, no use of potential nephrotoxic medication and normoglycemia.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative AKI	until day 5 after surgery	AKI according to KDIGO definition

Secondary Outcome Measures

Name	Time	Method
urine output (total ml)	after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery
length of hospital stay	up to 100 days after surgery
length of ICU stay	up to 100 days after surgery
Intensive care unit mortality	28 days and 90 days after surgery
hospital mortality	up to 100 days after surgery
usage of renal replacement therapy (hours)	up to 30 days after surgery
length of invasive respirator therapy (hours)	up to 30 days after surgery
creatinine in serum	12 hours, day 2, 3, 5 and 10 after surgery

Trial Locations

Locations (1)

University Hospital Wuerzburg, Dep. of Anesthesiology; 🇩🇪 Wuerzburg, Germany