NCT03813563

Brief Summary

In recent years, there has been a large amount of literature reports that normal saline can increase the incidence of renal injury in critically ill patients compared with balanced salt solution.However, no studies have compared the effects of different types of balanced salt solutions on the incidence of renal injury.

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
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 13, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 19, 2019

Last Update Submit

January 22, 2019

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • The incidence of acute kidney injury

    The incidence of acute kidney injury

    from admission to 28 days

Secondary Outcomes (3)

  • the incidency of CRRT events

    from admission to 28 days

  • the ventilation free days

    from admission to 28 days

  • the vasopressure free days

    from admission to 28 days

Study Arms (3)

Mix group

Patients who used two balanced salt solutions during icu stay

Drug: RLDrug: PLA

RL group

Patients who have only used lactated Ringer's during icu stay

Drug: RL

PLA group

Patients who have only used PlasmaLyte during icu stay

Drug: PLA

Interventions

RLDRUG

lactated Ringer's

Mix groupRL group
PLADRUG

PlasmaLyte

Mix groupPLA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All ICU admissions

You may qualify if:

  • All patients admitted to ICU

You may not qualify if:

  • Patients \<18 year old when admission
  • Patients who stay less than 24 hours in ICU
  • Patients who do not sufficient data for further analysis
  • Readmission patients during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 19, 2019

First Posted

January 23, 2019

Study Start

January 13, 2018

Primary Completion

December 15, 2018

Study Completion

February 1, 2019

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations

CN(1)