NCT03188614

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

March 8, 2017

Last Update Submit

June 14, 2017

Conditions

Shock

Keywords

shockcrystalloidacute kidney injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute kidney injury

    Diagnosis of acute kidney injury

    28-day

Secondary Outcomes (1)

  • Usage of renal replacement of therapy

    28-day

Study Arms (2)

Normal saline group

PLACEBO COMPARATOR

Shock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016.

Drug: Fluid resuscitation

Balanced solution group

EXPERIMENTAL

Shock patients who resuscitated with balanced solution were enrolled after June, 2016.

Drug: Fluid resuscitation

Interventions

Fluid resuscitationDRUG

The placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid.

Balanced solution groupNormal saline group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shock patients

You may not qualify if:

  • History of chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ShockAcute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Haibo Qiu, Doctor

    Southeast University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Xu, Docotor

CONTACT

13851417209xujingyuanmail@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2017

First Posted

June 15, 2017

Study Start

August 1, 2017

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share