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Hannover Dialysis Outcome Study

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00529139
Acronym
HAND-OUT
Enrollment
157
Registered
2007-09-14
Start date
2003-07-31
Completion date
2006-05-31
Last updated
2007-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Failure

Keywords

Extended dialysis, Acute kidney injury, Intensive care unit, Renal replacement therapy, Survival, Dialysis

Brief 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 (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.

Interventions

DEVICEStandard extended dialysis

Standard extended dialysis dosed to maintain plasma urea levels between 120-150 mg/dL (20 -25 mmol/L)

DEVICEIntensified extended dialysis

Intensified extended dialysis dosed to maintain near-normal plasma urea levels, i.e. \<90 mg/dL (\<15 mmol/L)

Sponsors

Fresenius AG
CollaboratorINDUSTRY
Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
SurvivalDay 14 after initiation of renal replacement therapy

Secondary

MeasureTime frame
Survival and renal recoveryDay 28 after initiation of renal replacement therapy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026