SepsisNCT03685214
Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
A study testing 0.9% saline and lactated Ringer's solution in people with Sepsis and Acute Kidney Injury, run by ZhiYong Peng at 1 site in China.
Trial summary
In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis, Acute Kidney Injury, Septic Shock
- What is being tested?
- 0.9% saline and lactated Ringer's solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to May 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed sepsis aged 18~75 and accepted therapy in ICU
Who cannot join
- Need of Renal replacement treatment
- End-stage renal failure
- pregnant woman
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital
Wuhan, Hubei, 434000
Ying Feng
About this study
In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.
Read the detailed description
During the study period，either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock, Sepsis, Severe
- Being tested
- 0.9% saline, lactated Ringer's solution
- Keywords
- sepsis, intensive care unit, acetated Ringer's solution, AKI, normal saline, prognosis, continuous renal replacement therapy
- Medical subject headings
- Sepsis, Acute Kidney Injury, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% salineDrug
Also called normal saline
we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.
lactated Ringer's solutionDrug
Also called Ringer's lactate
we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline | Experimental | We use 0.9% saline for resuscitation fluid in ICU septic patients Receives: Drug: 0.9% saline |
| Balanced Crystalloids | Experimental | We use acetated Ringer's solution for resuscitation fluid in ICU septic patients Receives: Drug: lactated Ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of kidney injury as defined by the KDIGO criteria.
Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury
Measured: 5 days after the admission
Need of renal replacement treatment
Investigators will assess patients' kidney function everyday
Measured: After the admission and before the discharge from ICU,average 15 days
Secondary outcomes (2)
ICU stay
the time of patients' requirement for critical care
Measured: After the admission and before the discharge from ICU,average 15 days
28 days mortality
the short time mortality
Measured: 28 days after the admission in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Mar 2019
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- One model using normal saline for resuscitation fluid,the other using acetated Ringer's solution
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZhiYong Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Sponsor-investigator, ZhiYong Peng, Zhongnan Hospital
- Investigators
- ZhiYong Peng, professor, Study director, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685214
- Sponsor's protocol ID
- 2018010
- Status last verified
- Oct 2018
- First submitted
- 15 Aug 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang J, Liu F, Wu Z, Jiang J, Wang B, Qian Y, Suo J, Li Y, Peng Z. ACETATE RINGER'S SOLUTION VERSUS NORMAL SALINE SOLUTION IN SEPSIS: A RANDOMIZED, CONTROLLED TRIAL. Shock. 2024 Apr 1;61(4):520-526. doi: 10.1097/SHK.0000000000002324. Epub 2024 Feb 1.
PubMed 38369528Liu F, Zhang J, Zhu Y, Su L, Li Y, He L, Yu L, Peng Z. Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial. Trials. 2021 Jan 25;22(1):89. doi: 10.1186/s13063-020-05007-5.
PubMed 33494795
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
- ClinicalTrials.gov ID
- NCT03685214
- Acronym / sponsor ID
- 2018010
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock, Sepsis, Severe
- Keywords
- sepsis, intensive care unit, acetated Ringer's solution, AKI, normal saline, prognosis, continuous renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ZhiYong PengUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 26 Sep 2018 (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 this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.
Detailed description
During the study period，either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One model using normal saline for resuscitation fluid,the other using acetated Ringer's solution
| Arm | Type | Receives |
|---|---|---|
| 0.9% saline | Experimental | Drug: 0.9% salineWe use 0.9% saline for resuscitation fluid in ICU septic patients |
| Balanced Crystalloids | Experimental | Drug: lactated Ringer's solutionWe use acetated Ringer's solution for resuscitation fluid in ICU septic patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed sepsis aged 18~75 and accepted therapy in ICU
Key exclusion criteria (3 listed)
- Need of Renal replacement treatment
- End-stage renal failure
- pregnant woman
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 |
|---|---|---|
| 0.9% salineAlso: normal salinewe use 0.9% saline in ICU patients with sepsis for resuscitation fluid. | Drug | 0.9% saline |
| lactated Ringer's solutionAlso: Ringer's lactatewe use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid. | Drug | Balanced Crystalloids |
Primary outcome
Development of kidney injury as defined by the KDIGO criteria.
Time frame: 5 days after the admission
Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury
Need of renal replacement treatment
Time frame: After the admission and before the discharge from ICU,average 15 days
Investigators will assess patients' kidney function everyday
2 secondary outcomes
ICU stay
Time frame: After the admission and before the discharge from ICU,average 15 days
28 days mortality
Time frame: 28 days after the admission in ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 38369528Zhang J, Liu F, Wu Z, Jiang J, Wang B, Qian Y, Suo J, Li Y, Peng Z. ACETATE RINGER'S SOLUTION VERSUS NORMAL SALINE SOLUTION IN SEPSIS: A RANDOMIZED, CONTROLLED TRIAL. Shock. 2024 Apr 1;61(4):520-526. doi: 10.1097/SHK.0000000000002324. Epub 2024 Feb 1.
- Derived from this study: PubMed 33494795Liu F, Zhang J, Zhu Y, Su L, Li Y, He L, Yu L, Peng Z. Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial. Trials. 2021 Jan 25;22(1):89. doi: 10.1186/s13063-020-05007-5.
- Individual participant dataSharing planned: Yes
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
ZhiYong Peng, professor study director
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% saline and lactated Ringer's solution in people with Sepsis and Acute Kidney Injury, run by ZhiYong Peng 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 3 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 26 Mar 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?
Contact Li He, investigator (008617798258617, helisoul@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of kidney injury as defined by the KDIGO criteria. (time frame: 5 days after the admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685214, which also lists 2 linked publications.
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 26 Mar 2019.