Effect of CVVH on NGAL in Septic AKI

Effect of Continuous Venovenous Hemofiltration on the Plasma Level of Neutrophil Gelatinase-associated Lipocalin in Critical Ill Patients With Septic Acute Kidney Injury

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Procedure: continuous venovenous hemofiltration

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: continuous renal replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0-12 hours

Collaborators and Investigators

• Sponsor: First People's Hospital of Chenzhou
• Investigators: Study Director: Dixian DX Luo, MS, Chenzhou First People Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: acute kidney injury; sepsis; continuous venovenous hemofiltration; neutrophil gelatinase-associated lipocalin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: FirstHospitalchenzhou