Value of Urine sTREM-1 on Early Predicting AKI in Sepsis

Sepsis Clinical Trial

Official title:

Value of Urine sTREM-1 on Early Predicting Secondary Acute Kidney Injury in Sepsis: a Mutilcenter and Prospective Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02920736
• Other study ID #: shoufa2016-1-5015
• Status: Active, not recruiting
• Phase: N/A
• First received: September 29, 2016
• Last updated: September 29, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Beijing Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the value of urine sTREM-1 on early predicting secondary acute kidney injury in sepsis

Description:

The clinical trial is a prospective, controlled study. All subjects were selected from among inpatients who were hospitalized between Sep.2016 and Dec.2018 in the Respiratory ICU, Surgical ICU and Emergency ICU of 6 general hospitals in Beijing. Based on the Sepsis 3.0,the population(500 subjects) selected met the diagnostic criteria. Based on the KDIGO (Nephrol Dial Transplant. 2012) defines AKI as 3 degrees, the subjects were divided into acute renal injury group (AKI group) and non-acute renal injury group (non-AKI group). Approximately 110 healthy volunteers enrolled as control group. Urine samples were collected from day 1 to day 28 in all patient groups (or to the terminal time point of death), serum samples were collected on days 1, 3, 5, 7, 10, and 14 and the samples were collected from healthy subjects on the day of enrollment. Blood was centrifuged at 3,000 rpm for 15 minutes, and urine at 2,000 rpm for 5 minutes. The supernatants were transferred to Eppendorf tubes and stored at -80°C. All the specimens were re-numbered before the experiment. Urine sTREM-1 was measured by a double antibody sandwich ELISA. This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2014-113-02). The following clinical datas were recorded for all patients through the unified database software: (1) basic clinical information: hospital number, gender, age, underlying disease, hospital admission. (2) Daily vital signs after admission: body temperature, blood pressure, heart rate, respiratory rate, 24h urine volume, Glasgow score. (3) APACHE II score and SOFA score: arterial blood gas analysis, blood routine, C-reactive protein, procalcitonin, blood biochemistry (liver function, renal function, brain natriuretic peptide, blood electrolytes) The APACHE II score and the SOFA score were calculated. (4) 28-day outcome (survival or death). Statistical analyses were conducted by SPSS 16.0 (SPSS, Chicago,IL, USA) and a two-tailed P < 0.05 was considered significant.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

All subjects meet the standards of sepsis 3.0 diagnostic criteria for the diagnosis of sepsis.

Exclusion Criteria:

The following situations can not occur when all subjects are enrolled

1. Age> 80 years or <18 years

2. Chronic renal insufficiency, renal transplantation

3. Blood purification treatment

4. AKI has occurred

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Toxemia

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Shijitan Hospital, First Hospitals affiliated to the China PLA General Hospital, Peking University Shougang Hospital

References & Publications (2)

Ad-hoc working group of ERBP, Fliser D, Laville M, Covic A, Fouque D, Vanholder R, Juillard L, Van Biesen W. A European Renal Best Practice (ERBP) position statement on the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines on acute kidney injury: part 1: definitions, conservative management and contrast-induced nephropathy. Nephrol Dial Transplant. 2012 Dec;27(12):4263-72. doi: 10.1093/ndt/gfs375. Epub 2012 Oct 8. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine soluble triggering receptor expressed on myeloid cells-1		3 years	No