Different Crystalloids on AKI in Shock

June 13, 2017 updated by: Jingyuan,Xu, Southeast University, China

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

The goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Fluid resuscitation is important to shock patients. Saline is the classical fluids for resuscitation. However, studies showed that resuscitation with saline could increase the incidence of hyperchloremia and acute kidney injury. Thus, the goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Zhongda Hospital Southeast University

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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Shock patients who need fluid resuscitation with risk factors of acute kidney injury

Description

Inclusion Criteria:

  • Shock patients who need fluid resuscitation with risk factors of acute kidney injury

Exclusion Criteria:

  • Patients with a history of chronic kidney injury and hemodialysis therapy

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Saline group
Patients resuscitated with saline
Other: Fluid resuscitation
Patients in the saline group were resuscitated with saline, patients in the other group were resuscitated with acetated Ringer's sodium
Acetated Ringer's sodium group
Patients resuscitated with Acetated Ringer's sodium
Other: Fluid resuscitation
Patients in the saline group were resuscitated with saline, patients in the other group were resuscitated with acetated Ringer's sodium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Application of renal replacement
Time Frame: 28 day
Application of renal replacement
28 day

Collaborators and Investigators

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

Sponsor

Southeast University, China

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)

June 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017ZDSYLL017P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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