NCT02536027

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 20, 2015

Last Update Submit

August 26, 2015

Conditions

Keywords

continuous venovenous hemofiltrationneutrophil gelatinase-associated lipocalinsepsisacute kidney injury

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

septic AKI patients

EXPERIMENTAL

septic AKI patients requiring CVVH

Procedure: continuous venovenous hemofiltration

Interventions

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.

Also known as: continuous renal replacement therapy
septic AKI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney InjurySepsis

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Dixian DX Luo, MS

    Chenzhou First people Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical Care Medicine

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 31, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 31, 2015

Record last verified: 2015-08