Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02536027
Previous Study | Return to List | Next Study

Effect of CVVH on NGAL in Septic AKI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536027
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Xingui Dai, First People's Hospital of Chenzhou

Brief Summary:
The plasma level of neutrophil gelatinase-associated lipocalin (NGAL) in critically ill patients with AKI is not affected by continuous venovenous hemofiltration (CVVH). However, it remains unclear if this also applies to sepsis-induced AKI, as considerable evidence suggests that the pathophysiology of septic AKI is different from other causes of AKI.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Procedure: continuous venovenous hemofiltration Not Applicable

Detailed Description:

Acute kidney injury (AKI) is an increasingly common and potentially catastrophic complication in critically ill patients. The incidence of AKI increases in recent years; about half of all patients in the intensive care units (ICU) develop AKI. AKI is associated with a significantly increased length of hospital stay and high mortality rates. Approximately, 50% of AKI is induced by sepsis.

Continuous renal replacement therapy (CRRT) has become routine for patients with AKI, chronic renal failure, fluid overload as well as oliguria in ICU. In clinical practice, continuous venovenous hemofiltration (CVVH) is actually the method of choice for CRRT in critically ill and hemodynamic instable patients. CVVH has significant beneficial effects on removing inflammatory cytokines, improving oxygen index, decreasing vasopressor requirements, increasing cardiac index, and regulating immune dysfunction, specifically in patients with septic shock. So far, there is no uniform standard to define the timing of discontinuation of CRRT for AKI, as predicting recovery of renal function in patients with AKI during CRRT is difficult. The Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) study suggested the urinary output > 500ml per day as the predictor for successful discontinuation of CRRT. However, the urinary output is often affected by clinical interventions (e.g. using diuretics). Thus, it is of great importance to find out a reliable biomarker to reflect the renal function of the patients who receiving CRRT. Cystatin (Cys) C has received the most interest in previous studies. The results showed serum Cys C concentrations were declined in different types of RRT (including intermittent hemodialysis and CVVH). This indicates Cys C is unfit as an indicator for persistent renal injury or renal recovery in critically ill patients during CRRT.

Neutrophil gelatinase-associated lipocalin (NGAL), a 25-kDa protein that covalently binds to gelatinase from neutrophils, is generally expressed at very low levels in several human tissues, however, in case of ischemia, infection, or toxic damage, NGAL rapidly released by activated neutrophils. Numerous studies have confirmed NGAL as a better indicator of AKI than serum creatinine (SCr). Schilder and colleagues reported that the plasma level of NGAL in critically ill patients with AKI is not affected by continuous venovenous hemofiltration (CVVH). However, it remains unclear if this also applies to sepsis-induced AKI, as considerable evidence suggests that the pathophysiology of septic AKI is different from other causes of AKI.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Continuous Venovenous Hemofiltration on the Plasma Level of Neutrophil Gelatinase-associated Lipocalin in Critical Ill Patients With Septic Acute Kidney Injury
Study Start Date : August 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: septic AKI patients
septic AKI patients requiring CVVH
Procedure: continuous venovenous hemofiltration
Continuous renal replacement therapy (CRRT) has become routine for patients with AKI, chronic renal failure, fluid overload as well as oliguria in ICU. In clinical practice, continuous venovenous hemofiltration (CVVH) is actually the method of choice for CRRT in critically ill and hemodynamic instable patients. CVVH has significant beneficial effects on removing inflammatory cytokines, improving oxygen index, decreasing vasopressor requirements, increasing cardiac index, and regulating immune dysfunction, specifically in patients with septic shock.
Other Name: continuous renal replacement therapy




Primary Outcome Measures :
  1. plasma level of neutrophil gelatinase-associated lipocalin [ Time Frame: 0-12 hours ]
    The specimens in the inlet, outlet and ultrafiltrate were obtained at the beginning of CVVH (T0) and 2 h (T2h), 4 h (T4h), 8 h (T8h), and 12 h (T12h) after setup of continuous renal replacement therapy (CRRT).The plasmatic NGAL level was measured with enzyme-linked immunosorbent assay (R&D Systems, UK, Lipocalin2/NGAL Duoset, DY1757).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive adult (>18 years) patients with septic AKI undergoing CRRT

Exclusion Criteria:

  • those with end-stage renal disease
  • those who had undergone renal transplant
  • those with cancer
  • those who had contracted acquired immunodeficiency syndrome
  • those who had undergone high-dose steroid treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536027


Sponsors and Collaborators
First People's Hospital of Chenzhou
Investigators
Layout table for investigator information
Study Director: Dixian DX Luo, MS Chenzhou First people Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Xingui Dai, Critical Care Medicine, First People's Hospital of Chenzhou
ClinicalTrials.gov Identifier: NCT02536027    
Other Study ID Numbers: FirstHospitalchenzhou
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015
Keywords provided by Xingui Dai, First People's Hospital of Chenzhou:
continuous venovenous hemofiltration
neutrophil gelatinase-associated lipocalin
sepsis
acute kidney injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases