Crystalloids for AKI in Shock Patients

June 14, 2017 updated by: Jingyuan,Xu, Southeast University, China

Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shock patients

Exclusion Criteria:

  • History of chronic renal failure

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal saline group
Shock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016.
Drug: Fluid resuscitation
The placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid.
Experimental: Balanced solution group
Shock patients who resuscitated with balanced solution were enrolled after June, 2016.
Drug: Fluid resuscitation
The placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute kidney injury
Time Frame: 28-day
Diagnosis of acute kidney injury
28-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage of renal replacement of therapy
Time Frame: 28-day
Usage of CRRT
28-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Principal Investigator: Haibo Qiu, Doctor, Southeast university

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 (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017ZDSYLL018P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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