Effect of CVVH on NGAL in Septic AKI
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
continuous venovenous hemofiltration
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring continuous venovenous hemofiltration, neutrophil gelatinase-associated lipocalin, sepsis, acute kidney injury
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
septic AKI patients
Arm Description
septic AKI patients requiring CVVH
Outcomes
Primary Outcome Measures
plasma level of neutrophil gelatinase-associated lipocalin
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02536027
First Posted
August 20, 2015
Last Updated
August 26, 2015
Sponsor
First People's Hospital of Chenzhou
1. Study Identification
Unique Protocol Identification Number
NCT02536027
Brief Title
Effect of CVVH on NGAL in Septic AKI
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Chenzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
continuous venovenous hemofiltration, neutrophil gelatinase-associated lipocalin, sepsis, acute kidney injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
septic AKI patients
Arm Type
Experimental
Arm Description
septic AKI patients requiring CVVH
Intervention Type
Procedure
Intervention Name(s)
continuous venovenous hemofiltration
Other Intervention Name(s)
continuous renal replacement therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
plasma level of neutrophil gelatinase-associated lipocalin
Description
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).
Time Frame
0-12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dixian DX Luo, MS
Organizational Affiliation
Chenzhou First people Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
27760529
Citation
Dai X, Li T, Zeng Z, Fu C, Wang S, Cai Y, Chen Z. The effect of continuous venovenous hemofiltration on neutrophil gelatinase-associated lipocalin plasma levels in patients with septic acute kidney injury. BMC Nephrol. 2016 Oct 19;17(1):154. doi: 10.1186/s12882-016-0363-y.
Results Reference
derived
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Effect of CVVH on NGAL in Septic AKI
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