BurnsCRRTNCT01501097
The Impact of Continuous Renal Replacement Therapy on the Outcomes of Burn Patients With Early Phase of Sepsis
A study testing Continuous Renal Replacement Therapy in people with Burns and Sepsis, run by Southwest Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to determine if early application of CRRT will result in an improvement of clinical outcomes of burn patients during the early phase of sepsis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Continuous Renal Replacement Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with documented sepsis
- clinically identified focus of infection associated with at least 2 SIRS -criteria and one or more sepsis-induced organ failures within the 24 hours -prior to inclusion
- age 18 to 70 years
- severe burned patients with 50% < TBSA < 85%
Who cannot join
- cirrhosis child class C
- too high APACHE II \& SOFA score at admission
- age over 70 years
- were presence of a malignant tumor, chronic renal insufficiency (serum creatinine > 133 µmol/L), moribund state, receiving immunosuppressive therapy or receiving any kind of renal replacement therapy before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Impact of Early Application of CRRT on the Outcomes of Burn Patients With Early Phase of Sepsis
The purpose of this study is to determine if early application of CRRT will result in an improvement of clinical outcomes of burn patients during the early phase of sepsis
Read the detailed description
The impact of Continuous Renal Replacement Therapy (CRRT) on the outcomes of patients with sepsis is controversial, and there is no consensus for the timing and dose of CRRT may improve the outcomes. The purpose of this prospective randomized study is to assess the effect of different CRRT intensity (25ml/kg/h or 50ml/kg/h) on the outcomes of burn patients with early phase of sepsis
- Being tested
- Continuous Renal Replacement Therapy
- Medical subject headings
- Burns, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Renal Replacement TherapyProcedure or surgery
Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described Receives: Procedure: Continuous Renal Replacement Therapy |
| early HV-crrt | Experimental | Not described Receives: Procedure: Continuous Renal Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum cytokine concentrations and clearance
0, 6, 12 , 24, 48, 96 hours post CRRT
Measured: 96 hours
Secondary outcomes (1)
28 and 90 days survival
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqiang Yuan, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501097
- Sponsor's protocol ID
- SWHCBS01
- Acronym
- CRRT
- Status last verified
- Dec 2011
- First submitted
- 20 Dec 2011
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Impact of Early Application of CRRT on the Outcomes of Burn Patients With Early Phase of Sepsis
- ClinicalTrials.gov ID
- NCT01501097
- Acronym / sponsor ID
- CRRT / SWHCBS01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- 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 purpose of this study is to determine if early application of CRRT will result in an improvement of clinical outcomes of burn patients during the early phase of sepsis
Detailed description
The impact of Continuous Renal Replacement Therapy (CRRT) on the outcomes of patients with sepsis is controversial, and there is no consensus for the timing and dose of CRRT may improve the outcomes. The purpose of this prospective randomized study is to assess the effect of different CRRT intensity (25ml/kg/h or 50ml/kg/h) on the outcomes of burn patients with early phase of sepsis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | Procedure: Continuous Renal Replacement Therapy |
| early HV-crrt | Experimental | Procedure: Continuous Renal Replacement Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with documented sepsis
- clinically identified focus of infection associated with at least 2 SIRS -criteria and one or more sepsis-induced organ failures within the 24 hours -prior to inclusion
- age 18 to 70 years
- severe burned patients with 50% < TBSA < 85%
Key exclusion criteria (4 listed)
- cirrhosis child class C
- too high APACHE II \& SOFA score at admission
- age over 70 years
- were presence of a malignant tumor, chronic renal insufficiency (serum creatinine > 133 µmol/L), moribund state, receiving immunosuppressive therapy or receiving any kind of renal replacement therapy before randomization
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 |
|---|---|---|
| Continuous Renal Replacement TherapyPatients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group | Procedure or surgery | Control group, early HV-crrt |
Primary outcome
Changes in serum cytokine concentrations and clearance
Time frame: 96 hours
0, 6, 12 , 24, 48, 96 hours post CRRT
1 secondary outcome
28 and 90 days survival
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Renal Replacement Therapy in people with Burns and Sepsis, run by Southwest Hospital, China at 1 site in China.
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 4 inclusion and 4 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 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in serum cytokine concentrations and clearance (time frame: 96 hours). 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 30 Dec 2011.