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NCT03141112 Clinical Trial

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

Severe Sepsis Clinical Trial

Official title:
The Benefits of Early Initiation of Continuous Renal Replacement Therapy (CRRT) in Patients With Severe Sepsis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03141112
Other study ID # ECRRT 51/16
Secondary ID
Status Enrolling by invitation
Phase N/A
First received May 2, 2017
Last updated May 3, 2017
Start date August 2016
Est. completion date December 2020

Study information
Verified date May 2017
Source University Hospital Olomouc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date December 2020
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• renal replacement therapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Radovan Uvizl

Outcome
Type Measure Description Time frame Safety issue
Other length of stay length of stay in hospital 3 months
Primary mortality yes/no 28 days
Secondary duration of mechanical ventilation days of mechanical ventilation including weening 28 days
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