ShockNCT03188614
Crystalloids for AKI in Shock Patients
A study testing Fluid resuscitation in people with Shock, run by Southeast University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Fluid resuscitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Oct 2018
- Phase
- Interventional
- 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
Who may be able to join
- Shock patients
Who cannot join
- History of chronic renal failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients
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.
- Conditions
- Shock
- Being tested
- Fluid resuscitation
- Keywords
- shock, crystalloid, acute kidney injury
- Medical subject headings
- Shock, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid resuscitationDrug
The placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline group | Placebo comparator | Shock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016. Receives: Drug: Fluid resuscitation |
| Balanced solution group | Experimental | Shock patients who resuscitated with balanced solution were enrolled after June, 2016. Receives: Drug: Fluid resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury
Diagnosis of acute kidney injury
Measured: 28-day
Secondary outcomes (1)
Usage of renal replacement of therapy
Usage of CRRT
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Haibo Qiu, Doctor, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188614
- Sponsor's protocol ID
- 2017ZDSYLL018P
- Status last verified
- Jun 2017
- First submitted
- 8 Mar 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients
- ClinicalTrials.gov ID
- NCT03188614
- Acronym / sponsor ID
- 2017ZDSYLL018P
- Conditions
- Shock
- Keywords
- shock, crystalloid, acute kidney injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 15 Jun 2017 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline group | Placebo comparator | Drug: Fluid resuscitationShock patients who resuscitated with normal saline were enrolled between June, 2015-June.2016. |
| Balanced solution group | Experimental | Drug: Fluid resuscitationShock patients who resuscitated with balanced solution were enrolled after June, 2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shock patients
Key exclusion criteria (1 listed)
- History of chronic renal failure
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 |
|---|---|---|
| Fluid resuscitationThe placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid. | Drug | Balanced solution group, Normal saline group |
Primary outcome
Incidence of acute kidney injury
Time frame: 28-day
Diagnosis of acute kidney injury
1 secondary outcome
Usage of renal replacement of therapy
Time frame: 28-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Haibo Qiu, Doctor principal investigator
Southeast University
Questions about this trial
What is this clinical trial studying?
A study testing Fluid resuscitation in people with Shock, run by Southeast University, 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 1 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Jingyuan Xu, Docotor (13851417209, xujingyuanmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury (time frame: 28-day). 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 15 Jun 2017.