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

NCT03141112 — Unknown, 200 participants, Radovan Uvizl

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT03141112
StatusUnknown
Study typeObservational
Enrollment200 (Estimated)
SponsorRadovan Uvizl (Other)
ConditionsSevere Sepsis
Interventionsrenal replacement therapy (Procedure)
Datesstart 2016-08-01, primary completion 2018-12-01 (estimated), completion 2020-12-01 (estimated), first posted 2017-05-04, last updated 2017-05-04

Related Papers Related Patents Related Grants Related Experts
All trials for Severe Sepsis All trials of renal replacement therapy

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
early CRRT initiationProcedure: renal replacement therapyPatients 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 initiationProcedure: renal replacement therapyPatients 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.
  • renal replacement therapy (Procedure)

+Outcome measures

Primary outcomes

  • mortality [28 days]: yes/no

Secondary outcomes

  • duration of mechanical ventilation [28 days]: days of mechanical ventilation including weening

Other outcomes

  • length of stay [3 months]: length of stay in hospital

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators

  • Radovan Uvizl, Principal investigator, UH Olomouc, Czech Republic