ShockNCT03155126
Different Crystalloids on AKI in Shock
An observational study of Shock, run by Southeast University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shock
- What is being tested?
- Fluid resuscitation
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jun 2017to Jul 2018
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Shock patients who need fluid resuscitation with risk factors of acute kidney injury
Who may be able to join
- Shock patients who need fluid resuscitation with risk factors of acute kidney injury
Who cannot join
- Patients with a history of chronic kidney injury and hemodialysis therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients
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.
Read the detailed description
Fluid resuscitation is important to shock patients. Saline is the classical fluids for resuscitation. However, studies showed that resuscitation with saline could increase the incidence of hyperchloremia and acute kidney injury. Thus, 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.
- Conditions
- Shock
- Being tested
- Fluid resuscitation
- Keywords
- shock, acute kidney injury, crystalloid
- 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 resuscitationOther
Patients in the saline group were resuscitated with saline, patients in the other group were resuscitated with acetated Ringer's sodium
| Study group | Role | What they receive |
|---|---|---|
| Saline group | Patients resuscitated with saline Receives: Other: Fluid resuscitation | |
| Acetated Ringer's sodium group | Patients resuscitated with Acetated Ringer's sodium Receives: Other: Fluid resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury
Incidence of acute kidney injury
Measured: 28 day
Secondary outcomes (1)
Application of renal replacement
Application of renal replacement
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 posted16 May 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155126
- Sponsor's protocol ID
- 2017ZDSYLL017P01
- Status last verified
- Jun 2017
- First submitted
- 11 May 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients
- ClinicalTrials.gov ID
- NCT03155126
- Acronym / sponsor ID
- 2017ZDSYLL017P01
- Conditions
- Shock
- Keywords
- shock, acute kidney injury, crystalloid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 16 May 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.
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.
Detailed description
Fluid resuscitation is important to shock patients. Saline is the classical fluids for resuscitation. However, studies showed that resuscitation with saline could increase the incidence of hyperchloremia and acute kidney injury. Thus, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline group | – | Other: Fluid resuscitationPatients resuscitated with saline |
| Acetated Ringer's sodium group | – | Other: Fluid resuscitationPatients resuscitated with Acetated Ringer's sodium |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Shock patients who need fluid resuscitation with risk factors of acute kidney injury
Key inclusion criteria (1 listed)
- Shock patients who need fluid resuscitation with risk factors of acute kidney injury
Key exclusion criteria (1 listed)
- Patients with a history of chronic kidney injury and hemodialysis therapy
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 resuscitationPatients in the saline group were resuscitated with saline, patients in the other group were resuscitated with acetated Ringer's sodium | Other | Acetated Ringer's sodium group, Saline group |
Primary outcome
Incidence of acute kidney injury
Time frame: 28 day
Incidence of acute kidney injury
1 secondary outcome
Application of renal replacement
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 14 Jun 2017.
- 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 Shock, run by Southeast University, China 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 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 14 Jun 2017. 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?
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 14 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.