Acute Renal FailurePhase 2/3CONVINTNCT01228123
Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients
A Phase 2/3 study testing RRT for acute kidney failure using the CVVH method and RRT for acute kidney failure using the IHD (intermittent HD) in people with Acute Renal Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite manifold improvements in ICU care. At present, it is not clear if the method chosen for renal replacement therapy, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- RRT for acute kidney failure using the CVVH method and RRT for acute kidney failure using the IHD (intermittent HD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to Jan 2008
- Phase
- Phase 2/3
- 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
Who may be able to join
- all ICU patients requiring renal replacement therapy
Who cannot join
- patient denies informed consent
- patient not requiring intensive care therapy
- kidney transplanted patients
- chronic renal failure (serum creatinine > 3mg/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Clinical Trial of the Effect of Continuous Versus Intermittent Renal Replacement Therapy on the Mortality and Outcome of Acute Renal Failure in ICU Patients
The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite manifold improvements in ICU care. At present, it is not clear if the method chosen for renal replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration (CVVH), might impact on the outcome of these patients. For this purpose, a prospective randomised clinical study of the effect of continuous versus intermittent renal replacement therapy on the mortality and outcome of acute renal failure will be performed.
Read the detailed description
please see above
- Conditions
- Acute Renal Failure
- Being tested
- RRT for acute kidney failure using the CVVH method, RRT for acute kidney failure using the IHD (intermittent HD)
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRT for acute kidney failure using the CVVH methodOther
Also called does not apply
patients randomized to receive CVVH
RRT for acute kidney failure using the IHD (intermittent HD)Other
Also called does not apply
patients randomized to receive IHD
| Study group | Role | What they receive |
|---|---|---|
| CVVH arm | Active comparator | Not described Receives: Other: RRT for acute kidney failure using the CVVH method |
| IHD arm | Active comparator | Not described Receives: Other: RRT for acute kidney failure using the IHD (intermittent HD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 2 weeks after RRT
Measured: 2 weeks after RRT in follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startJan 2002
- Primary completionOct 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Achim Joerres, MD, Principal investigator, Charite University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228123
- Sponsor's protocol ID
- CONVINT
- Acronym
- CONVINT
- Status last verified
- Jul 2010
- First submitted
- 25 Oct 2010
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
PubMed 34519356Schefold JC, von Haehling S, Pschowski R, Bender T, Berkmann C, Briegel S, Hasper D, Jorres A. The effect of continuous versus intermittent renal replacement therapy on the outcome of critically ill patients with acute renal failure (CONVINT): a prospective randomized controlled trial. Crit Care. 2014 Jan 10;18(1):R11. doi: 10.1186/cc13188.
PubMed 24405734
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Clinical Trial of the Effect of Continuous Versus Intermittent Renal Replacement Therapy on the Mortality and Outcome of Acute Renal Failure in ICU Patients
- ClinicalTrials.gov ID
- NCT01228123
- Acronym / sponsor ID
- CONVINT / CONVINT
- Conditions
- Acute Renal Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 26 Oct 2010 (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 mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite manifold improvements in ICU care. At present, it is not clear if the method chosen for renal replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration (CVVH), might impact on the outcome of these patients. For this purpose, a prospective randomised clinical study of the effect of continuous versus intermittent renal replacement therapy on the mortality and outcome of acute renal failure will be performed.
Detailed description
please see above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVVH arm | Active comparator | Other: RRT for acute kidney failure using the CVVH method |
| IHD arm | Active comparator | Other: RRT for acute kidney failure using the IHD (intermittent HD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all ICU patients requiring renal replacement therapy
Key exclusion criteria (4 listed)
- patient denies informed consent
- patient not requiring intensive care therapy
- kidney transplanted patients
- chronic renal failure (serum creatinine > 3mg/dl)
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 |
|---|---|---|
| RRT for acute kidney failure using the CVVH methodAlso: does not applypatients randomized to receive CVVH | Other | CVVH arm |
| RRT for acute kidney failure using the IHD (intermittent HD)Also: does not applypatients randomized to receive IHD | Other | IHD arm |
Primary outcome
Survival at 2 weeks after RRT
Time frame: 2 weeks after RRT in follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
- Derived from this study: PubMed 34519356Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
- Derived from this study: PubMed 24405734Schefold JC, von Haehling S, Pschowski R, Bender T, Berkmann C, Briegel S, Hasper D, Jorres A. The effect of continuous versus intermittent renal replacement therapy on the outcome of critically ill patients with acute renal failure (CONVINT): a prospective randomized controlled trial. Crit Care. 2014 Jan 10;18(1):R11. doi: 10.1186/cc13188.
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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.
Achim Joerres, MD principal investigator
Charite University Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RRT for acute kidney failure using the CVVH method and RRT for acute kidney failure using the IHD (intermittent HD) in people with Acute Renal Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 25 May 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival at 2 weeks after RRT (time frame: 2 weeks after RRT in follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228123, which also lists 2 linked publications.
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 25 May 2011.