Prevention of Postoperative Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— PrevenAKI  

Official title:

Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02583945
• Other study ID #: 022015
• Status: Withdrawn
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: May 2018
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age > 65 years

• chronic kidney disease

• diabetes mellitus, chronic heart, lung or liver disease

• hemodynamic instability (intra and/or post-operative)

• trauma, burn injury, major surgery, usage of x-ray contrast and sepsis.

Exclusion criteria:

• Age < 18 years

• pregnancy

• kidney graft recipient

• chronic renal disease with or without renal replacement therapy and cardiac surgery.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Procedure:
• kidney treatment bundle (KDIGO)
Application of the measures of the kidney treatment bundle.

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg, Dep. of Anesthesiology	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative AKI	AKI according to KDIGO definition	until day 5 after surgery
Secondary	Intensive care unit mortality		28 days and 90 days after surgery
Secondary	hospital mortality		up to 100 days after surgery
Secondary	usage of renal replacement therapy (hours)		up to 30 days after surgery
Secondary	length of invasive respirator therapy (hours)		up to 30 days after surgery
Secondary	creatinine in serum		12 hours, day 2, 3, 5 and 10 after surgery
Secondary	urine output (total ml)		after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery
Secondary	length of hospital stay		up to 100 days after surgery
Secondary	length of ICU stay		up to 100 days after surgery