Prevention of Postoperative Acute Kidney Injury

NCT02583945 | Withdrawn

• 1 other identifier: 022015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

acute kidney injury; hemodynamic stabilisation; nephrotoxic medication

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative AKI

  AKI according to KDIGO definition

  until day 5 after surgery

Secondary Outcomes (8)

• 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

Study Arms (1)

kidney treatment bundle (KDIGO)

EXPERIMENTAL

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.

Procedure: kidney treatment bundle (KDIGO)

Interventions

kidney treatment bundle (KDIGO) PROCEDURE

Application of the measures of the kidney treatment bundle.

kidney treatment bundle (KDIGO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years
• pregnancy
• kidney graft recipient
• chronic renal disease with or without renal replacement therapy and cardiac surgery.

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Hospital Wuerzburg, Dep. of Anesthesiology

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Christian Wunder, MD

  University of Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chair and leading senior physician

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 22, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

DE (1)