NCT03155126

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

May 11, 2017

Last Update Submit

June 13, 2017

Conditions

Shock

Keywords

shockacute kidney injurycrystalloid

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute kidney injury

    Incidence of acute kidney injury

    28 day

Secondary Outcomes (1)

  • Application of renal replacement

    28 day

Study Arms (2)

Saline group

Patients resuscitated with saline

Other: Fluid resuscitation

Acetated Ringer's sodium group

Patients resuscitated with Acetated Ringer's sodium

Other: Fluid resuscitation

Interventions

Fluid resuscitationOTHER

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 groupSaline group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

Location

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Doctor

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 16, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

CN(1)