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Hannover Dialysis Outcome Study

NCT ID: NCT00529139

Last Updated: 2007-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Failure

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Standard extended dialysis

Intervention Type DEVICE

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

B

Group Type ACTIVE_COMPARATOR

Intensified extended dialysis

Intervention Type DEVICE

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

Interventions

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Standard extended dialysis

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

Intervention Type DEVICE

Intensified extended dialysis

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius AG

INDUSTRY

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Principal Investigators

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Danilo Fliser, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36416787 (View on PubMed)

Ghosh 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.

Reference Type DERIVED
PMID: 25855898 (View on PubMed)

Other Identifiers

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MHH - SLED - 01

Identifier Type: -

Identifier Source: org_study_id