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Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Primary Purpose

Sepsis, Acute Kidney Injury, Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.9% saline
lactated Ringer's solution
Sponsored by
ZhiYong Peng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, intensive care unit, acetated Ringer's solution, AKI, normal saline, prognosis, continuous renal replacement therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongnan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

0.9% saline

Balanced Crystalloids

Arm Description

We use 0.9% saline for resuscitation fluid in ICU septic patients

We use acetated Ringer's solution for resuscitation fluid in ICU septic patients

Outcomes

Primary Outcome Measures

Development of kidney injury as defined by the KDIGO criteria.
Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury
Need of renal replacement treatment
Investigators will assess patients' kidney function everyday

Secondary Outcome Measures

ICU stay
the time of patients' requirement for critical care
28 days mortality
the short time mortality

Full Information

First Posted
August 15, 2018
Last Updated
March 23, 2019
Sponsor
ZhiYong Peng
Collaborators
Wu Jieping Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03685214
Brief Title
Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
Official Title
Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ZhiYong Peng
Collaborators
Wu Jieping Medical Foundation

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Acute Kidney Injury, Septic Shock, Sepsis, Severe
Keywords
sepsis, intensive care unit, acetated Ringer's solution, AKI, normal saline, prognosis, continuous renal replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
One model using normal saline for resuscitation fluid,the other using acetated Ringer's solution
Masking
Participant
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.9% saline
Arm Type
Experimental
Arm Description
We use 0.9% saline for resuscitation fluid in ICU septic patients
Arm Title
Balanced Crystalloids
Arm Type
Experimental
Arm Description
We use acetated Ringer's solution for resuscitation fluid in ICU septic patients
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
normal saline
Intervention Description
we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.
Intervention Type
Drug
Intervention Name(s)
lactated Ringer's solution
Other Intervention Name(s)
Ringer's lactate
Intervention Description
we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.
Primary Outcome Measure Information:
Title
Development of kidney injury as defined by the KDIGO criteria.
Description
Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury
Time Frame
5 days after the admission
Title
Need of renal replacement treatment
Description
Investigators will assess patients' kidney function everyday
Time Frame
After the admission and before the discharge from ICU,average 15 days
Secondary Outcome Measure Information:
Title
ICU stay
Description
the time of patients' requirement for critical care
Time Frame
After the admission and before the discharge from ICU,average 15 days
Title
28 days mortality
Description
the short time mortality
Time Frame
28 days after the admission in ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li He, investigator
Phone
008617798258617
Email
helisoul@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li He
Phone
008617798258617
Email
helisoul@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZhiYong Peng, professor
Organizational Affiliation
Zhongnan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhongnan Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
434000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Feng

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33494795
Citation
Liu F, Zhang J, Zhu Y, Su L, Li Y, He L, Yu L, Peng Z. Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial. Trials. 2021 Jan 25;22(1):89. doi: 10.1186/s13063-020-05007-5.
Results Reference
derived

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Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

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