Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221013
Status:
COMPLETED
Last Update Posted:
2009-02-27
First Post:
2005-09-14
Brief Title:
Augmented Vs Normal Renal Replacement Therapy in Severe Acute Renal Failure ARF
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
Multicentre Unblinded Open Label Randomised Controlled Trial to Assess the Effect of Augmented Vs Normal Continuous Renal Replacement Therapy CRRT on 90-Day All-Cause Mortality of Intensive Care Unit Patients With Severe Acute Renal Failure ARF
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to determine if increasing the dose of continuous renal replacement therapy CRRT reduces 90-day all cause mortality in Intensive Care Unit ICU patients with severe acute renal failure ARF
Detailed Description:
Study Title - Multicentre Unblinded Randomised Controlled Trial to assess the effect of Augmented vs Normal Continuous Renal Replacement Therapy CRRT on 90-day all-cause mortality of Intensive Care Unit Patients with Severe Acute Renal Failure ARF
Clinical Phase - IV
Study Rationale - This study will provide high quality evidence from a mulit-center randomised controlled trial about the comparative effects of different targets for CRRT dose in patients with ARF treated in the Australasian intensive care setting This evidence will have direct relevance to decisions about the care of critically ill patients admitted to intensive care units in Australia and New Zealand If this study confirms the treatment effect reported in the Lancet study augmented dose CRRT is likely too become the standard of treatment saving 250-300 livesyear in Australia and 15000 livesyear worldwide
Trial Design - The proposed study will compare an augmented CRRT regimen to deliver an effluent rate of 40 mlkghr compared to normal CRRT at an effluent rate of 25mlkghr in ICU patients with severe ARF
Subject Participation - 90 days
Rationale for Number of Subjects - Assuming a 90-day mortality rate of 60 in our control group the study of 1500 patients will have 90 power of detecting an 85 absolute reduction from a 90-day mortality of 60 in the control group to 515 in the intervention group P005
Approximate duration of Study - 36 months
Study Objectives
Primary - The primary study outcome is death from all causes at 90 days after randomisation
Secondary
Death within the in the intensive care unit
Death within 28 days of randomisation
Death prior to hospital discharge
Length of ICU stay
Length of hospital stay
The need for and duration of other organ support inotropicvasopressor support and positive pressure ventilation
CRRT-free days
Dialysis-independent survival
Criteria for Inclusion
1 The treating clinician believes that the patient requires CRRT for acute renal failure
2 The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with higher intensity or lower intensity CRRT
3 The treating clinicians anticipate treating the patient with CRRT for at least 72 hours
4 Informed consent has been obtained
5 The patient fulfils at least ONE of the following clinical criteria for initiating CRRT
1 Oliguria urine output 100ml6hr that has been unresponsive to fluid resuscitation measures
2 Hyperkalemia K 65 mmolL
3 Severe acidemia pH 72
4 Urea 25 mmolliter
5 Creatinine 300 micromolL in the setting of ARF
6 Clinically significant organ oedema in the setting of ARF eg lung
Criteria for Exclusion
1 Patient age is 18 years
2 Death is imminent 24 hours
3 There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol
4 The patient has been treated with CRRT or other dialysis previously during the same hospital admission
5 The patient was on maintenance dialysis prior to the current hospitalisation
6 The patients body weight is 60 kg or 120kg
7 Any other major illness that in the investigators judgment will substantially increase the risk associated with the subjects participation in this study
Approximate Number of Subjects - 1500
Approximate Number of Study Centres - 35 centres distributed in both Australia and New Zealand will participate in the study
Treatment Administration - Each participant will be randomised to receive CRRT in the technical form of CVVHDF either at an intensity of 25mlkghr of effluent flownormal CRRT or 40 mlkghr of effluent flow augmented CRRT
Safety Evaluation - Safety for individual patients will be assessed on an ongoing basis by physical examination including vital signs outputs from dialysis machine records laboratory assessments and monitoring of adverse events Overall study safety will be ensured by an Independent Data Safety Monitoring Committee independent from all Trial investigators which will perform ongoing review of predefined safety parameters and study conduct
Efficacy Evaluation - Overall survival at 90 days post randomisation
Statistical Analysis - The interim analyses will be conducted when approximately 500 and 1000 patients have completed 90 day follow up as dictated by the Data Safety Monitoring Committee The final analysis will occur when outcome data for the target 1500 subjects is available At interim and final analysis the baseline and outcome variables will be compared using Students t test Chi squared and the Mann-Whitney U test as appropriate Survival analysis will be assessed using the Mantel-Cox test The final statistical analysis will be performed according to a pre-determined statistical analysis plan Critical Care and Resuscitation 2009 in press
Clinical Phase - IV
Study Rationale - This study will provide high quality evidence from a mulit-center randomised controlled trial about the comparative effects of different targets for CRRT dose in patients with ARF treated in the Australasian intensive care setting This evidence will have direct relevance to decisions about the care of critically ill patients admitted to intensive care units in Australia and New Zealand If this study confirms the treatment effect reported in the Lancet study augmented dose CRRT is likely too become the standard of treatment saving 250-300 livesyear in Australia and 15000 livesyear worldwide
Trial Design - The proposed study will compare an augmented CRRT regimen to deliver an effluent rate of 40 mlkghr compared to normal CRRT at an effluent rate of 25mlkghr in ICU patients with severe ARF
Subject Participation - 90 days
Rationale for Number of Subjects - Assuming a 90-day mortality rate of 60 in our control group the study of 1500 patients will have 90 power of detecting an 85 absolute reduction from a 90-day mortality of 60 in the control group to 515 in the intervention group P005
Approximate duration of Study - 36 months
Study Objectives
Primary - The primary study outcome is death from all causes at 90 days after randomisation
Secondary
Death within the in the intensive care unit
Death within 28 days of randomisation
Death prior to hospital discharge
Length of ICU stay
Length of hospital stay
The need for and duration of other organ support inotropicvasopressor support and positive pressure ventilation
CRRT-free days
Dialysis-independent survival
Criteria for Inclusion
1 The treating clinician believes that the patient requires CRRT for acute renal failure
2 The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with higher intensity or lower intensity CRRT
3 The treating clinicians anticipate treating the patient with CRRT for at least 72 hours
4 Informed consent has been obtained
5 The patient fulfils at least ONE of the following clinical criteria for initiating CRRT
1 Oliguria urine output 100ml6hr that has been unresponsive to fluid resuscitation measures
2 Hyperkalemia K 65 mmolL
3 Severe acidemia pH 72
4 Urea 25 mmolliter
5 Creatinine 300 micromolL in the setting of ARF
6 Clinically significant organ oedema in the setting of ARF eg lung
Criteria for Exclusion
1 Patient age is 18 years
2 Death is imminent 24 hours
3 There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol
4 The patient has been treated with CRRT or other dialysis previously during the same hospital admission
5 The patient was on maintenance dialysis prior to the current hospitalisation
6 The patients body weight is 60 kg or 120kg
7 Any other major illness that in the investigators judgment will substantially increase the risk associated with the subjects participation in this study
Approximate Number of Subjects - 1500
Approximate Number of Study Centres - 35 centres distributed in both Australia and New Zealand will participate in the study
Treatment Administration - Each participant will be randomised to receive CRRT in the technical form of CVVHDF either at an intensity of 25mlkghr of effluent flownormal CRRT or 40 mlkghr of effluent flow augmented CRRT
Safety Evaluation - Safety for individual patients will be assessed on an ongoing basis by physical examination including vital signs outputs from dialysis machine records laboratory assessments and monitoring of adverse events Overall study safety will be ensured by an Independent Data Safety Monitoring Committee independent from all Trial investigators which will perform ongoing review of predefined safety parameters and study conduct
Efficacy Evaluation - Overall survival at 90 days post randomisation
Statistical Analysis - The interim analyses will be conducted when approximately 500 and 1000 patients have completed 90 day follow up as dictated by the Data Safety Monitoring Committee The final analysis will occur when outcome data for the target 1500 subjects is available At interim and final analysis the baseline and outcome variables will be compared using Students t test Chi squared and the Mann-Whitney U test as appropriate Survival analysis will be assessed using the Mantel-Cox test The final statistical analysis will be performed according to a pre-determined statistical analysis plan Critical Care and Resuscitation 2009 in press
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 352550 | None | None | None |