NCT03141112

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

May 2, 2017

Last Update Submit

May 3, 2017

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

  • mortality

    yes/no

    28 days

Secondary Outcomes (1)

  • duration of mechanical ventilation

    28 days

Other Outcomes (1)

  • length of stay

    3 months

Study Arms (2)

early CRRT initiation

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.

Procedure: renal replacement therapy

late CRRT initiation

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.

Procedure: renal replacement therapy

Interventions

renal replacement therapyPROCEDURE
early CRRT initiationlate CRRT initiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient in severe sepsis (reaching criteria for severe sepsis), both gender, age over 18 years old, admisset in ICU.

You may qualify if:

  • reaching criteria of severe sepsis, ICU admission

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Radovan Uvizl

    UH Olomouc, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MUDr.

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

May 4, 2017

Record last verified: 2017-05