Biomarker-Guided Intervention to Prevent Acute Kidney Injury after Major Surgery; The Prospective Multicenter Randomized Controlled Interventional Trial

Recruiting

Conditions: AKI (Acute Kidney Injury)
Renal Insufficiency
10038430

Registration Number: NL-OMON56592

Lead Sponsor: niversity Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Patients after major surgery who need to be admitted to the ICU
2. Age > 18 years
3. [TIMP-2]*[IGFBP7] >= 0.3 4-18 hours after surgery
4. Inserted jugular central venous line and a urinary catheter
5. Written informed consent
6. At least one additional risk factor for AKI:
a. Age > 75 years
b. Critical illness such as ongoing requirement of vasopressors or mechanical
ventilation postoperatively
c. Pre- existing chronic kidney disease (eGFR< 60 ml/ min)
d. Intraoperative use of radio contrast agents.

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Pre- existing high stages of chronic kidney disease (>=stage 4 i.e. eGFR < 30
ml/ min)
3. Kidney transplant within the last 12 months
4. Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
5. Anuria at inclusion time
6. Preexisting AKI
7. Renal replacement therapy within the last 90 days
8. Indication for renal replacement at the time of inclusion
9. Participation in another interventional trial that investigates a
drug/intervention that affects
the kidney function
10. Persons held in an institution by legal or official order
11. Persons with any kind of dependency on the investigator or employed by the
responsible
institution or investigator

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is<br /><br>- occurrence of moderate or severe AKI according to the KDIGO criteria within 3<br /><br>days after<br /><br>major surgery (see 16.2) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Adherence to the implementation of the KDIGO bundle<br /><br>2. Occurrence and severity of acute kidney injury within 3 days after major<br /><br>surgery<br /><br>3. Change in biomarker values during 12 hours after initial measuring of the<br /><br>[TIMP-2]*[IGFBP7]<br /><br>4. Free-days of mechanical organ support through to day 3 .<br /><br>5. Free-days of vasopressors through day 3<br /><br>6. Need of RRT at day 30 and 90<br /><br>7. Duration of RRT at day 30 and 90<br /><br>8. Renal recovery at day 90<br /><br>9. 30-day and 90-day mortality<br /><br>10. ICU length-of-stay and Hospital length-of-stay<br /><br>11. MAKE90 (major adverse kidney events) at day 90 </p><br>