Critical IllnessNCT03813563
Lactated Ringer's and PlasmaLyte in Critically Ill Adults
An observational study of Critical Illness, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- RL and PLA
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2018to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All ICU admissions
Who may be able to join
- All patients admitted to ICU
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical care medicine of West China Hospital
Chengdu, Sichuan, 610041
About this study
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.
- Conditions
- Critical Illness
- Being tested
- RL, PLA
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLDrug
lactated Ringer's
PLADrug
PlasmaLyte
| Study group | Role | What they receive |
|---|---|---|
| Mix group | Patients who used two balanced salt solutions during icu stay Receives: Drug: RL; Drug: PLA | |
| RL group | Patients who have only used lactated Ringer's during icu stay Receives: Drug: RL | |
| PLA group | Patients who have only used PlasmaLyte during icu stay Receives: Drug: PLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute kidney injury
The incidence of acute kidney injury
Measured: from admission to 28 days
Secondary outcomes (3)
the incidency of CRRT events
the incidency of CRRT events
Measured: from admission to 28 days
the ventilation free days
the ventilation free days
Measured: from admission to 28 days
the vasopressure free days
the vasopressure free days
Measured: from admission to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start13 Jan 2018
- Primary completion15 Dec 2018
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813563
- Sponsor's protocol ID
- RL vs Plalyte
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactated Ringer's and PlasmaLyte in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT03813563
- Acronym / sponsor ID
- RL vs Plalyte
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 13 Jan 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- Feb 2019 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mix group | – | Drug: RL, Drug: PLAPatients who used two balanced salt solutions during icu stay |
| RL group | – | Drug: RLPatients who have only used lactated Ringer's during icu stay |
| PLA group | – | Drug: PLAPatients who have only used PlasmaLyte during icu stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ICU admissions
Key inclusion criteria (1 listed)
- All patients admitted to ICU
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLlactated Ringer's | Drug | Mix group, RL group |
| PLAPlasmaLyte | Drug | Mix group, PLA group |
Primary outcome
The incidence of acute kidney injury
Time frame: from admission to 28 days
The incidence of acute kidney injury
3 secondary outcomes
the incidency of CRRT events
Time frame: from admission to 28 days
the ventilation free days
Time frame: from admission to 28 days
the vasopressure free days
Time frame: from admission to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute kidney injury (time frame: from admission to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.