Overview

This trial is active, not recruiting.

Conditions acute kidney injury, sepsis
Sponsor Chinese PLA General Hospital
Collaborator First Hospitals affiliated to the China PLA General Hospital
Start date January 2016
End date December 2018
Trial size 500 participants
Trial identifier NCT02920736, shoufa2016-1-5015

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Based on definition of sepsis with Sepsis 3.0 and AKI was defined using KDIGO(Kidney Disease: Improving Global Outcomes) consensus definition of AKI.The group was the secondary AKI in sepsis patients
The group was the non-AKI in sepsis patients
Approximately 110 persons(18-80years) with healthy physical examination and without liver and kidney dysfunction

Primary Outcomes

Measure
urine soluble triggering receptor expressed on myeloid cells-1
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Value of Urine sTREM-1 on Early Predicting Secondary Acute Kidney Injury in Sepsis: a Mutilcenter and Prospective Clinical Study
Principal investigator lixin xie, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.