- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685214
Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
March 23, 2019 updated by: ZhiYong Peng
In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
During the study period,either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li He, investigator
- Phone Number: 008617798258617
- Email: helisoul@163.com
Study Contact Backup
- Name: Li He
- Phone Number: 008617798258617
- Email: helisoul@163.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 434000
- Recruiting
- Zhongnan Hospital
-
Contact:
- Ying Feng
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients diagnosed sepsis aged 18~75 and accepted therapy in ICU
Exclusion Criteria:
- Need of Renal replacement treatment
- End-stage renal failure
- pregnant woman
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.9% saline
We use 0.9% saline for resuscitation fluid in ICU septic patients
|
we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.
Other Names:
|
Experimental: Balanced Crystalloids
We use acetated Ringer's solution for resuscitation fluid in ICU septic patients
|
we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of kidney injury as defined by the KDIGO criteria.
Time Frame: 5 days after the admission
|
Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury
|
5 days after the admission
|
Need of renal replacement treatment
Time Frame: After the admission and before the discharge from ICU,average 15 days
|
Investigators will assess patients' kidney function everyday
|
After the admission and before the discharge from ICU,average 15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU stay
Time Frame: After the admission and before the discharge from ICU,average 15 days
|
the time of patients' requirement for critical care
|
After the admission and before the discharge from ICU,average 15 days
|
28 days mortality
Time Frame: 28 days after the admission in ICU
|
the short time mortality
|
28 days after the admission in ICU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: zhiyong peng, professor, Zhongnan Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
May 1, 2021
Study Registration Dates
First Submitted
August 15, 2018
First Submitted That Met QC Criteria
September 24, 2018
First Posted (Actual)
September 26, 2018
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 23, 2019
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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