Acute Kidney FailurePhase 4HAND-OUTNCT00529139
Hannover Dialysis Outcome Study
A Phase 4 study testing Standard extended dialysis and Intensified extended dialysis in people with Acute Kidney Failure, run by Hannover Medical School at 1 site in Germany.
Trial summary
Mortality rates of patients with acute kidney injury in the intensive care unit have changed little over the past few decades despite significant advances in supportive care. Few interventions have been shown to result in an improvement of in-hospital mortality of these patients, with dose of renal replacement therapy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- Standard extended dialysis and Intensified extended dialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2003to May 2006
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non post-renal AKI with RRT dependency indicated by oliguria/anuria <30mL/h >6 hours prior to inclusion
- loss of kidney function of >30% within 48 hours prior to inclusion
- hyperkalemia >6.5 mmol/L
- severe acidosis with pH<7.15
Who cannot join
- pre-existing chronic kidney disease (CKD) as defined by an estimated glomerular filtration rate <50mL/min or a plasma creatinine concentration >1.7 mg/dL (>150 µmol/L) more than 10 days prior to initiation of the first RRT
- presence of AV-fistula or dialysis catheter
- participation in another study
- consent denial or withdrawal
- need for extra corporal membrane oxygenation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hannover-Dialysis-Outcome (HAN-D-OUT)-Study: Comparison of Standard Versus Intensified Extended Dialysis in Treatment of Patients With Acute Kidney Injury in the Intensive-Care Unit
Mortality rates of patients with acute kidney injury in the intensive care unit have changed little over the past few decades despite significant advances in supportive care. Few interventions have been shown to result in an improvement of in-hospital mortality of these patients, with dose of renal replacement therapy (RRT) being one of the most important. Patients undergoing continuous veno-venous hemofiltration had better outcomes with ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h. In a different trial, intermittent hemodialysis on a daily basis resulted in better control of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute renal failure than thrice weekly hemodialysis. In the present study we examine survival and renal recovery in critically ill patients with acute kidney injury that are treated with a currently recommended (standard) dose of RRT, and patients that receive intensified RRT.
- Conditions
- Acute Kidney Failure
- Being tested
- Standard extended dialysis, Intensified extended dialysis
- Keywords
- Extended dialysis, Acute kidney injury, Intensive care unit, Renal replacement therapy, Survival, Dialysis
- 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.
Standard extended dialysisDevice
Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)
Intensified extended dialysisDevice
Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Device: Standard extended dialysis |
| B | Active comparator | Not described Receives: Device: Intensified extended dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Day 14 after initiation of renal replacement therapy
Secondary outcomes (1)
Survival and renal recovery
Measured: Day 28 after initiation of renal replacement therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startJul 2003
- Study completionMay 2006
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 Kidney FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius AG
- Investigators
- Danilo Fliser, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529139
- Sponsor's protocol ID
- MHH - SLED - 01
- Acronym
- HAND-OUT
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
PubMed 36416787Ghosh CC, Thamm K, Berghelli AV, Schrimpf C, Maski MR, Abid T, Milam KE, Rajakumar A, Santel A, Kielstein JT, Ahmed A, Thickett D, Wang K, Chase M, Donnino MW, Aird WC, Haller H, David S, Parikh SM. Drug Repurposing Screen Identifies Foxo1-Dependent Angiopoietin-2 Regulation in Sepsis. Crit Care Med. 2015 Jul;43(7):e230-40. doi: 10.1097/CCM.0000000000000993.
PubMed 25855898
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hannover-Dialysis-Outcome (HAN-D-OUT)-Study: Comparison of Standard Versus Intensified Extended Dialysis in Treatment of Patients With Acute Kidney Injury in the Intensive-Care Unit
- ClinicalTrials.gov ID
- NCT00529139
- Acronym / sponsor ID
- HAND-OUT / MHH - SLED - 01
- Conditions
- Acute Kidney Failure
- Keywords
- Extended dialysis, Acute kidney injury, Intensive care unit, Renal replacement therapy, Survival, Dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Fresenius AG
- Study start
- Jul 2003
- Study completion
- May 2006 (actual)
- First posted
- 14 Sep 2007 (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.
Mortality rates of patients with acute kidney injury in the intensive care unit have changed little over the past few decades despite significant advances in supportive care. Few interventions have been shown to result in an improvement of in-hospital mortality of these patients, with dose of renal replacement therapy (RRT) being one of the most important. Patients undergoing continuous veno-venous hemofiltration had better outcomes with ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h. In a different trial, intermittent hemodialysis on a daily basis resulted in better control of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute renal failure than thrice weekly hemodialysis. In the present study we examine survival and renal recovery in critically ill patients with acute kidney injury that are treated with a currently recommended (standard) dose of RRT, and patients that receive intensified RRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Standard extended dialysis |
| B | Active comparator | Device: Intensified extended dialysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non post-renal AKI with RRT dependency indicated by oliguria/anuria <30mL/h >6 hours prior to inclusion
- loss of kidney function of >30% within 48 hours prior to inclusion
- hyperkalemia >6.5 mmol/L
- severe acidosis with pH<7.15
Key exclusion criteria (5 listed)
- pre-existing chronic kidney disease (CKD) as defined by an estimated glomerular filtration rate <50mL/min or a plasma creatinine concentration >1.7 mg/dL (>150 µmol/L) more than 10 days prior to initiation of the first RRT
- presence of AV-fistula or dialysis catheter
- participation in another study
- consent denial or withdrawal
- need for extra corporal membrane oxygenation 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 |
|---|---|---|
| Standard extended dialysisStandard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L) | Device | A |
| Intensified extended dialysisIntensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. <90 mg/dL (<15 mmol/L) | Device | B |
Primary outcome
Survival
Time frame: Day 14 after initiation of renal replacement therapy
1 secondary outcome
Survival and renal recovery
Time frame: Day 28 after initiation of renal replacement therapy
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 17 Sep 2007.
- Derived from this study: PubMed 36416787Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
- Derived from this study: PubMed 25855898Ghosh CC, Thamm K, Berghelli AV, Schrimpf C, Maski MR, Abid T, Milam KE, Rajakumar A, Santel A, Kielstein JT, Ahmed A, Thickett D, Wang K, Chase M, Donnino MW, Aird WC, Haller H, David S, Parikh SM. Drug Repurposing Screen Identifies Foxo1-Dependent Angiopoietin-2 Regulation in Sepsis. Crit Care Med. 2015 Jul;43(7):e230-40. doi: 10.1097/CCM.0000000000000993.
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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.
Danilo Fliser, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard extended dialysis and Intensified extended dialysis in people with Acute Kidney Failure, run by Hannover Medical School 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 4 inclusion and 5 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 17 Sep 2007. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: Day 14 after initiation of renal replacement therapy). 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 NCT00529139, 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 17 Sep 2007.