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

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

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:
  • normal saline
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:
  • Ringer's lactate

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

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

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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