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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Wen-Jo Ko, MD, PhD contact

+886-2-23562082

kdw@ntumc.org

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Wen-Jo Ko, MD, PhD, +886-2-23562082, kdw@ntumc.org

    Wen-Jo Ko, MD, PhD

    Recruiting

Other trials in Taiwan

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.

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.

  1. the mortality of postoperative acute renal failure

Secondary outcomes (1)
  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.

  1. First posted23 Mar 2007 (estimated)
  2. Study startJul 2006
  3. Study completionDec 2012 (estimated)

Resources

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
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 11473662
  • de 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

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.

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