Crystalloids for AKI in Shock Patients
Primary Purpose
Shock
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid resuscitation
Sponsored by
About this trial
This is an interventional prevention trial for Shock focused on measuring shock, crystalloid, acute kidney injury
Eligibility Criteria
Inclusion Criteria:
- Shock patients
Exclusion Criteria:
- History of chronic renal failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Normal saline group
Balanced solution group
Arm Description
Shock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016.
Shock patients who resuscitated with balanced solution were enrolled after June, 2016.
Outcomes
Primary Outcome Measures
Incidence of acute kidney injury
Diagnosis of acute kidney injury
Secondary Outcome Measures
Usage of renal replacement of therapy
Usage of CRRT
Full Information
NCT ID
NCT03188614
First Posted
March 8, 2017
Last Updated
June 14, 2017
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT03188614
Brief Title
Crystalloids for AKI in Shock Patients
Official Title
Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fluid resuscitation is important in shock therapy, but the choice of fluids, especially the choice of crystalloid is under debate. It is said that normal saline is related to hyperchloremia, which might lead to acute kidney injury. Thus the hypothesis of the study is to explicit whether balanced salt solution could reduce the incidence of acute kidney injury when compared with normal saline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
Keywords
shock, crystalloid, acute kidney injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal saline group
Arm Type
Placebo Comparator
Arm Description
Shock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016.
Arm Title
Balanced solution group
Arm Type
Experimental
Arm Description
Shock patients who resuscitated with balanced solution were enrolled after June, 2016.
Intervention Type
Drug
Intervention Name(s)
Fluid resuscitation
Intervention Description
The placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid.
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury
Description
Diagnosis of acute kidney injury
Time Frame
28-day
Secondary Outcome Measure Information:
Title
Usage of renal replacement of therapy
Description
Usage of CRRT
Time Frame
28-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Shock patients
Exclusion Criteria:
History of chronic renal failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyuan Xu, Docotor
Phone
13851417209
Email
xujingyuanmail@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibo Qiu, Doctor
Organizational Affiliation
Southeast University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Crystalloids for AKI in Shock Patients
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