Severe SepsisNCT03141112
The Benefits of Early Initiation of Continual Renal Replacement Therapy in Patients With Severe Sepsis
An observational study of Severe Sepsis, run by Radovan Uvizl.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- renal replacement therapy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient in severe sepsis (reaching criteria for severe sepsis), both gender, age over 18 years old, admisset in ICU.
Who may be able to join
- reaching criteria of severe sepsis, ICU admission
Who cannot join
- pregnant women, younger than 18 years, reaching contraindications for initiation of renal replacement therapy
About this study
Official title: The Benefits of Early Initiation of Continuous Renal Replacement Therapy (CRRT) in Patients With Severe Sepsis
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.
Read the 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.
- Conditions
- Severe Sepsis
- Being tested
- renal replacement therapy
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal replacement therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
yes/no
Measured: 28 days
Secondary outcomes (1)
duration of mechanical ventilation
days of mechanical ventilation including weening
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startAug 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radovan Uvizl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Radovan Uvizl, University Hospital Olomouc
- Investigators
- Radovan Uvizl, Principal investigator, UH Olomouc, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141112
- Sponsor's protocol ID
- ECRRT 51/16
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Early Initiation of Continuous Renal Replacement Therapy (CRRT) in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT03141112
- Acronym / sponsor ID
- ECRRT 51/16
- Conditions
- Severe Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Radovan UvizlUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early CRRT initiation | – | Procedure: 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 initiation | – | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient in severe sepsis (reaching criteria for severe sepsis), both gender, age over 18 years old, admisset in ICU.
Key inclusion criteria (1 listed)
- reaching criteria of severe sepsis, ICU admission
Key exclusion criteria (1 listed)
- pregnant women, younger than 18 years, reaching contraindications for initiation of renal replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal replacement therapy | Procedure or surgery | early CRRT initiation, late CRRT initiation |
Primary outcome
mortality
Time frame: 28 days
yes/no
1 secondary outcome
duration of mechanical ventilation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Sepsis
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radovan Uvizl principal investigator
UH Olomouc, Czech Republic
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis, run by Radovan Uvizl.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.