The Benefits of Early Initiation of Continual Renal Replacement Therapy in Patients With Severe Sepsis

• Conditions: Severe Sepsis
• Interventions: Procedure: renal replacement therapy

• Registration Number: NCT03141112
• Lead Sponsor: Radovan Uvizl

Brief Summary

The study will evaluate the benefit of early initiation of CRRT in the initial phase of severe sepsis in patients admitted to the ICU. Primary evaluated end-point is 28-day mortality. Secondarily evaluated end-point is length of ICU-stay, length of stay in hospital, duration of mechanical ventilation. There are two groups. One group of participants with early CRRT initiation and another group with late CRRT initiation. Reference group no CRRT.

Detailed Description

The aim is to determine the optimal timing of initiation of CRRT with respect to the degree and duration of acute kidney injury (AKI) in ICU patients. The CRRT parameters and the duration of therapy will be monitored, depending on initial biochemical and clinical values of the patient. Part of the study is the follow-up of patients with a 3-month delay.

Study Timeline

• Study Start: 2016-08
• Status Verified: 2017-05
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Study First Posted: 2017-05-04
• Last Update Posted: 2017-05-04
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• reaching criteria of severe sepsis, ICU admission

Exclusion Criteria

• pregnant women, younger than 18 years, reaching contraindications for initiation of renal replacement therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
early CRRT initiation	renal replacement therapy	Patients in ICU with severe sepsis, both gender, adult, over 18 years od age. Initiation of renal replacement therapy up to 48 hours after reaching criteria of severe sepsis.
late CRRT initiation	renal replacement therapy	Patients in ICU with severe sepsis, both gender, adult, over 18 years od age. Initiation of renal replacement therapy after 48 hours after reaching criteria of severe sepsis.

Primary Outcome Measures

Name	Time	Method
mortality	28 days	yes/no

Secondary Outcome Measures

Name	Time	Method
duration of mechanical ventilation	28 days	days of mechanical ventilation including weening