High cut-off Continuous venovenous haemodialysis (CVVHD) to improve haemodynamic stability and Organ function scores in patients treated for acute renal failure after Systemic inflammatory response Syndrome (SIRS)/septic shock

Not Applicable

Completed

• Conditions: Acute renal failure after SIRS/septic shock; Urological and Genital Diseases; Renal failure

• Registration Number: ISRCTN77656437
• Lead Sponsor: Gambro Dialysatoren GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-24
• Study Completion: 2008-12-31
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Fulfilling at least two of the SIRS criteria as defined by the American College of Chest Physicians (ACCP)/Society of Critical Care Medicine (SCCM) Consensus Conference
2. Having signs of renal dysfunction
3. Requirement for catecholamine administration (norepinephrine or others)
4. Acute Physiology And Chronic Health Evaluation (APACHE II) score at enrolment greater than or equal to 19 and less than or equal to 30

Exclusion Criteria

1. Lack of written informed consent from patients or a legally authorized surrogate
2. Duration of septic shock greater than 4 days
3. Hypoproteinaemia (characterized by serum albumin less than 18 g/l)
4. End stage renal failure
5. Known active malignancy
6. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
7. Age younger than 18 years or older than 80 years
8. Known pregnancy
9. Immunosuppression after transplantation
10. Participation in another clinical study
11. Renal replacement therapy greater than 24 hours before randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Dosage of vasopressors<br> 2. Mean arterial pressure<br> 3. Heart rate<br> 4. Central venous pressure<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Sequential Organ Failure Assessment (SOFA) score<br> 2. Survival at 28 days<br> 3. Length of need for catecholamine application<br> 4. Length of need for mechanical ventilation<br> 5. Length of need for renal replacement therapy<br> 6. Length of stay in intensive care unit (ICU)<br>