NCT01251081

Brief Summary

In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2004

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
Last Updated

December 1, 2010

Status Verified

January 1, 2004

Enrollment Period

5.6 years

First QC Date

November 30, 2010

Last Update Submit

November 30, 2010

Conditions

Keywords

high volume hemofiltrationsepsisacute kidney injurysurvival

Outcome Measures

Primary Outcomes (1)

  • 90 days survival

    The primary study outcome was death from any cause within 90 days. Results were analyzed by Kaplan-Meier survival curves

Secondary Outcomes (1)

  • length of stay in the ICU and hospital

Study Arms (2)

extra high volume hemofiltration

EXPERIMENTAL

extra high volume hemofiltration (85 mL/kg/h, EHVHF)

Other: extra high volume hemofiltration

high volume hemofiltration

SHAM COMPARATOR

high volume hemofiltration (50 mL/kg/h, HVHF)

Other: high volume hemofiltration

Interventions

extra high volume hemofiltration (85 mL/kg/h, EHVHF)

extra high volume hemofiltration

high volume hemofiltration (50 mL/kg/h, HVHF)

high volume hemofiltration

Eligibility Criteria

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

You may qualify if:

  • met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH \< 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).

You may not qualify if:

  • were presence of a malignant tumor, chronic renal insufficiency (serum creatinine \>133 µmol/L), or receiving any kind of renal replacement therapy before randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kidney disease center, the first affiliated hospital, medical college of Zhejiang university

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

SepsisAcute Kidney Injury

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • jianghua chen, MD

    Kidney disease center, the first affiliated hospital, medical college of Zhejiang university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 1, 2010

Study Start

January 1, 2004

Primary Completion

August 1, 2009

Study Completion

June 1, 2010

Last Updated

December 1, 2010

Record last verified: 2004-01

Locations