Clinical trial NCT02920736: Value of Urine sTREM-1 on Early Predicting AKI in Sepsis
Official title: Value of Urine sTREM-1 on Early Predicting Secondary Acute Kidney Injury in Sepsis: a Mutilcenter and Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Sepsis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: First Hospitals affiliated to the China PLA General Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing Chao Yang Hospital
name: Peking University Shougang Hospital
name: Beijing Anzhen Hospital
First posted: 2016-09-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.All subjects were diagnosed with sepsis, based on the Sepsis 3.0.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: urine soluble triggering receptor expressed on myeloid cells-1
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: lixin xie, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. No abstract available.