NCT00875888

Brief Summary

This study will assess the influence of the High Cut-Off (HCO) CVVHD treatment on the disease progression in septic patients. The primary aim of the study is to evaluate whether HCO CVVHD leads to a significant improvement of the hemodynamic status (mean arterial pressure, vasopressor requirements) in septic patients in comparison to CVVHD treatment with conventional high-flux filters. For the HCO-group the investigators expect a 50% lower dosage of vasopressors needed to maintain an adequate organ perfusion.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

5.3 years

First QC Date

January 9, 2009

Last Update Submit

March 11, 2025

Conditions

Systemic Inflammatory Response SyndromeKidney Failure, Acute

Outcome Measures

Primary Outcomes (4)

  • Dosage of vasopressors

    day 1 to day 5

  • Mean arterial pressure

    day before inclusion and day 1 to day 5

  • Heart rate

    day before inclusion and day 1 to day 5

  • Central venous pressure

    day before inclusion and day 1 to day 5

Secondary Outcomes (6)

  • Sequential organ failure assessment (SOFA) score

    at ICU admission, at inclusion and day 1 to day 5

  • Survival

    28 days

  • Length of need for catecholamine application

    28 days follow up

  • Length of need for mechanical ventilation

    28 days

  • Length of need for renal replacement therapy

    28 days

  • +1 more secondary outcomes

Study Arms (2)

HCO

EXPERIMENTAL

High cut-off filters HCO1100

Device: continuous venovenous hemodialysis

control

ACTIVE COMPARATOR

conventional high-flux filters

Device: continuous venovenous hemodialysis

Interventions

continuous venovenous hemodialysisDEVICE

dialysate flow rate 35 ml/h/kg. Blood flow rate should be aimed at 200 ml/min, but not less than 150 ml/min. Bicarbonate- or lactate-buffered solutions will be used as dialysis fluids. Study dialyzers will be changed routinely every 24 h or earlier if the filter is obstructed by clotting.

HCOcontrol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfilling at least two of the SIRS criteria as defined by the American College of Chest Physicians (ACCP)/Society of Critical Care Medicine (SCCM) Consensus Conference
  • Having signs of renal dysfunction
  • Requirement for catecholamine administration (norepinephrine or others)
  • Acute Physiology And Chronic Health Evaluation (APACHE II) score at enrolment greater than or equal to 19 and less than or equal to 30

You may not qualify if:

  • Lack of written informed consent from patients or a legally authorized surrogate
  • Duration of septic shock greater than 4 days
  • Hypoproteinemia (characterized by serum albumin less than 18 g/l)
  • End stage renal failure
  • Known active malignancy
  • Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Age younger than 18 years or older than 80 years
  • Known pregnancy
  • Immunosuppression after transplantation
  • Participation in another clinical study
  • Renal replacement therapy greater than 24 hours before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Leopold Franzens Universität Innsbruck

Innsbruck, 6020, Austria

Location

Medizinische Klinik mit Schwerpunkt Nephrologie Charite, Campus Mitte

Berlin, 10117, Germany

Location

Charité-Virchow Klinik

Berlin, 13353, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Related Publications (5)

  • Morgera S, Haase M, Kuss T, Vargas-Hein O, Zuckermann-Becker H, Melzer C, Krieg H, Wegner B, Bellomo R, Neumayer HH. Pilot study on the effects of high cutoff hemofiltration on the need for norepinephrine in septic patients with acute renal failure. Crit Care Med. 2006 Aug;34(8):2099-104. doi: 10.1097/01.CCM.0000229147.50592.F9.

    PMID: 16763508BACKGROUND

  • Morgera S, Haase M, Rocktaschel J, Bohler T, von Heymann C, Vargas-Hein O, Krausch D, Zuckermann-Becker H, Muller JM, Kox WJ, Neumayer HH. High permeability haemofiltration improves peripheral blood mononuclear cell proliferation in septic patients with acute renal failure. Nephrol Dial Transplant. 2003 Dec;18(12):2570-6. doi: 10.1093/ndt/gfg435.

    PMID: 14605279BACKGROUND

  • Morgera S, Rocktaschel J, Haase M, Lehmann C, von Heymann C, Ziemer S, Priem F, Hocher B, Gohl H, Kox WJ, Buder HW, Neumayer HH. Intermittent high permeability hemofiltration in septic patients with acute renal failure. Intensive Care Med. 2003 Nov;29(11):1989-95. doi: 10.1007/s00134-003-2003-9. Epub 2003 Sep 3.

    PMID: 12955174BACKGROUND

  • Morgera S, Haase M, Rocktaschel J, Bohler T, Vargas-Hein O, Melzer C, Krausch D, Kox WJ, Baumann G, Beck W, Gohl H, Neumayer HH. Intermittent high-permeability hemofiltration modulates inflammatory response in septic patients with multiorgan failure. Nephron Clin Pract. 2003;94(3):c75-80. doi: 10.1159/000072024.

    PMID: 12902634BACKGROUND

  • Morgera S, Slowinski T, Melzer C, Sobottke V, Vargas-Hein O, Volk T, Zuckermann-Becker H, Wegner B, Muller JM, Baumann G, Kox WJ, Bellomo R, Neumayer HH. Renal replacement therapy with high-cutoff hemofilters: Impact of convection and diffusion on cytokine clearances and protein status. Am J Kidney Dis. 2004 Mar;43(3):444-53. doi: 10.1053/j.ajkd.2003.11.006.

    PMID: 14981602BACKGROUND

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeAcute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Werner Beck, Dr.

    Gambro Dialysatoren GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

April 6, 2009

Study Start

February 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

AU(1)DE(3)