Acute Renal FailureNCT00451373
Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study
A study testing CVVH and SLED, Vancomycin and Daptomycin in people with Acute Renal Failure and Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We examine the prognosis and etiology of postoperative acute renal failure Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Renal Failure, Sepsis, Postoperative
- What is being tested?
- CVVH and SLED, Vancomycin and Daptomycin
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2006to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postoperative acute renal failure
Who cannot join
- Patients with ECMO or IABP
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wen-Jo Ko, MD, PhD, +886-2-23562082, kdw@ntumc.org
Wen-Jo Ko, MD, PhD
About this study
We examine the prognosis and etiology of postoperative acute renal failure
Read the detailed description
Postoperative acute renal failure is a serious complication resulting in a prolonged stay and high mortality. Acute renal failure (ARF) develops in 5 to 30% of patients who undergo surgery, and for all causes, it is associated with mortality rates of 60-90%. Despite advances in supportive care and innovations in renal replacement therapies over the past three decades, the mortality rate for these patients remains high. In the previous analysis of NSARF (National Taiwan University Hospital-Surgical Intense Care Unit- acute renal failure database), the mortality rate of acute renal failure patients in SICU is 66.4%, dialysis dependent rate after ARF is 5% and renal recovery rate is 28.6%. Therefore, the issue concerned is to increase the survival rate and renal recovery rate after acute renal failure.
Perioperative ischemic reperfusion injury may result in acute renal failure (ARF), from which patients can invariably recover. However, there remains a large number of patients whose kidneys fail to recover from ARF, and therefore long-term dialysis is required. The dys-regulation of the inflammatory response in critically ill patients has been implicated as an important mechanism underlying the development of multiple organ system dysfunction, septic shock, and death. Furthermore, an increase in oxidative stress is considered an important pathogenic mechanism in the development of ischemic and toxic renal tubular injury. We hypothesize that extensive immune dys-regulation and increased oxidative stress might be an important factor leading to ARF, and/or associated with their all-cause mortality in critically ill patients.
In this study, we will find out (1) first year, the relationship between cytokine storm and free radical storm with urine output during post-surgical ARF, and the effect of renal replacement therapy on serum cytokines and free radical level (2) 2nd year, the difference outcome between low low-efficient daily dialysis (SLEDD), and low low-efficient daily dialysis-hemofiltration (SLEDD-f), the pharmacokinetics of the SLEDD (3) the 3rd year, we sill established the disease severity score of post-operative ARF patients. (NSARF score) and focus on long-term outcomes for survivors of postoperative ARF. From diagnosis to prognosis, we will incorporate important markers of disease diagnosis, treatment and long term outcome. Finally, we hope to improve the mortality and the life quality of postoperative ARF.
- Conditions
- Acute Renal Failure, Sepsis, Postoperative
- Being tested
- CVVH and SLED, Vancomycin, Daptomycin, FX60, AV600 (dialyzer)
- Keywords
- ARF, dialysis, cytokine, free radical, major operations
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVVH and SLEDDevice
VancomycinDrug
DaptomycinDrug
FX60, AV600 (dialyzer)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
the mortality of postoperative acute renal failure
Secondary outcomes (1)
the cytokine and free radical change of postoperative renal failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startJul 2006
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kwan-Dun Wu, MD, PhD, Principal investigator, National Taiwan University HosptialVinCent Wu, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451373
- Sponsor's protocol ID
- 9561709099
- Other IDs
- 31MD03
- Status last verified
- Jan 2007
- First submitted
- 22 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marshall MR, Golper TA, Shaver MJ, Alam MG, Chatoth DK. Sustained low-efficiency dialysis for critically ill patients requiring renal replacement therapy. Kidney Int. 2001 Aug;60(2):777-85. doi: 10.1046/j.1523-1755.2001.060002777.x.
PubMed 11473662de Mendonca A, Vincent JL, Suter PM, Moreno R, Dearden NM, Antonelli M, Takala J, Sprung C, Cantraine F. Acute renal failure in the ICU: risk factors and outcome evaluated by the SOFA score. Intensive Care Med. 2000 Jul;26(7):915-21. doi: 10.1007/s001340051281.
PubMed 10990106
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study
- ClinicalTrials.gov ID
- NCT00451373
- Acronym / sponsor ID
- 9561709099
- Conditions
- Acute Renal Failure, Sepsis, Postoperative
- Keywords
- ARF, dialysis, cytokine, free radical, major operations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We examine the prognosis and etiology of postoperative acute renal failure
Detailed description
Postoperative acute renal failure is a serious complication resulting in a prolonged stay and high mortality. Acute renal failure (ARF) develops in 5 to 30% of patients who undergo surgery, and for all causes, it is associated with mortality rates of 60-90%. Despite advances in supportive care and innovations in renal replacement therapies over the past three decades, the mortality rate for these patients remains high. In the previous analysis of NSARF (National Taiwan University Hospital-Surgical Intense Care Unit- acute renal failure database), the mortality rate of acute renal failure patients in SICU is 66.4%, dialysis dependent rate after ARF is 5% and renal recovery rate is 28.6%. Therefore, the issue concerned is to increase the survival rate and renal recovery rate after acute renal failure.
Perioperative ischemic reperfusion injury may result in acute renal failure (ARF), from which patients can invariably recover. However, there remains a large number of patients whose kidneys fail to recover from ARF, and therefore long-term dialysis is required. The dys-regulation of the inflammatory response in critically ill patients has been implicated as an important mechanism underlying the development of multiple organ system dysfunction, septic shock, and death. Furthermore, an increase in oxidative stress is considered an important pathogenic mechanism in the development of ischemic and toxic renal tubular injury. We hypothesize that extensive immune dys-regulation and increased oxidative stress might be an important factor leading to ARF, and/or associated with their all-cause mortality in critically ill patients.
In this study, we will find out (1) first year, the relationship between cytokine storm and free radical storm with urine output during post-surgical ARF, and the effect of renal replacement therapy on serum cytokines and free radical level (2) 2nd year, the difference outcome between low low-efficient daily dialysis (SLEDD), and low low-efficient daily dialysis-hemofiltration (SLEDD-f), the pharmacokinetics of the SLEDD (3) the 3rd year, we sill established the disease severity score of post-operative ARF patients. (NSARF score) and focus on long-term outcomes for survivors of postoperative ARF. From diagnosis to prognosis, we will incorporate important markers of disease diagnosis, treatment and long term outcome. Finally, we hope to improve the mortality and the life quality of postoperative ARF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postoperative acute renal failure
Key exclusion criteria (1 listed)
- Patients with ECMO or IABP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVVH and SLED | Device | – |
| Vancomycin | Drug | – |
| Daptomycin | Drug | – |
| FX60, AV600 (dialyzer) | Device | – |
Primary outcome
the mortality of postoperative acute renal failure
1 secondary outcome
the cytokine and free radical change of postoperative renal failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2007.
- Background: PubMed 11473662Marshall MR, Golper TA, Shaver MJ, Alam MG, Chatoth DK. Sustained low-efficiency dialysis for critically ill patients requiring renal replacement therapy. Kidney Int. 2001 Aug;60(2):777-85. doi: 10.1046/j.1523-1755.2001.060002777.x.
- Background: PubMed 10990106de Mendonca A, Vincent JL, Suter PM, Moreno R, Dearden NM, Antonelli M, Takala J, Sprung C, Cantraine F. Acute renal failure in the ICU: risk factors and outcome evaluated by the SOFA score. Intensive Care Med. 2000 Jul;26(7):915-21. doi: 10.1007/s001340051281.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwan-Dun Wu, MD, PhD principal investigator
National Taiwan University Hosptial
VinCent Wu, MD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVVH and SLED, Vancomycin and Daptomycin in people with Acute Renal Failure and Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Jo Ko, MD, PhD (+886-2-23562082, kdw@ntumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mortality of postoperative acute renal failure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451373, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2007.