Critical IllnessPhase 3BaSICSNCT02875873
Balanced Solution Versus Saline in Intensive Care Study
A Phase 3 study testing Plasma-Lyte, Saline 0.9% and Slow infusion speed in people with Critical Illness and Acute Kidney Injury, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Kidney Injury
- What is being tested?
- Plasma-Lyte, Saline 0.9% and Slow infusion speed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,075 participants
- Where
- 1 siteBrazil
- Study dates
- 27 May 2017to 28 Feb 2021
- Phase
- Phase 3
- 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
- Need for plasma expansion, and the clinician considers that Plasma-Lyte® or 0.9% saline are equally appropriate for patients, with no specific indications or contraindications for any of the fluids or for rapid or slow infusion.
- Patients not expected to be discharged on the day after their admission.
- At least one of the following risk factors for acute renal injury:
- Age ≥ 65 years
- Hypotension (mean arterial pressure [MAP] < 65 mmHg or systolic blood pressure [SBP] < 90 mmHg) or use of vasopressors
- Sepsis
Show all 10Show fewer
- Use of invasive mechanical ventilation or of continuous noninvasive mechanical ventilation (including high-flow nasal cannula) > 12 hours
- Oliguria (< 0.5 mL/kg/hour for ≥ 3 hours)
- Serum creatinine ≥ 1.2 mg/dL for women or ≥ 1.4 mg/dL for men
- Liver cirrhosis or acute liver failure
Who cannot join
- Age < 18 years
- Acute renal failure treated with renal replacement therapy (RRT) or expected to require RRT within the next 6 hours
- Severe hyponatremia (serum sodium ≤ 120 mmol/L)
- Severe hypernatremia (serum sodium ≥ 160 mmol/L)
- Death considered imminent and inevitable within 24 hours
- Patients with suspected or confirmed brain death
- Patients under exclusive palliative care
- Patients previously enrolled in the BaSICS study
Trial locations and contacts
1 site in 1 country.
About this study
A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients
Read the detailed description
Pragmatic, multicenter, 2x2 factorial randomized study. Severe patients admitted to the ICU at moderate to high risk for death or acute kidney injury will be randomly allocated to receive a balanced crystalloid solution (Plasma-Lyte®) or 0.9% saline and to receive crystalloids by rapid bolus infusion (999 mL/h) or slow infusion (333 mL/h) whenever plasma expansion is needed.
- Conditions
- Critical Illness, Acute Kidney Injury
- Being tested
- Plasma-Lyte, Saline 0.9%, Slow infusion speed, Fast Infusion Speed
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-LyteDrug
Plasma-Lyte will be used for fluid expansion and maintenance
Saline 0.9%Drug
Also called Normal Saline
Saline 0.9% will be used for fluid expansion and maintenance
Slow infusion speedOther
Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. NOTE: This intervention will not be blinded.
Fast Infusion SpeedOther
Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. NOTE: This intervention will not be blinded.
| Study group | Role | What they receive |
|---|---|---|
| Plasma-Lyte, Slow Infusion | Experimental | Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. Receives: Drug: Plasma-Lyte; Other: Slow infusion speed |
| Plasma-Lyte, Fast Infusion | Experimental | Plasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. Receives: Drug: Plasma-Lyte; Other: Fast Infusion Speed |
| Saline 0.9%, Slow Infusion | Experimental | Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. Receives: Drug: Saline 0.9%; Other: Slow infusion speed |
| Saline 0.9%, Fast Infusion | Experimental | Saline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. Receives: Drug: Saline 0.9%; Other: Fast Infusion Speed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 90 days
Secondary outcomes (4)
Renal failure requiring renal replacement therapy
Measured: 90 days
Renal Injury (KDIGO equal or greater than 2)
Measured: Days 3 and 7
Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)
Measured: Days 3 and 7
Mechanical ventilation free days
Measured: 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 Aug 2016 (estimated)
- Study start27 May 2017
- Primary completion2 Mar 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11,075 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, MD, PhD, Study chair, Hospital do CoracaoFernando G Zampieri, MD, Principal investigator, Hospital do CoracaoNilton Brandao, MD, PhD, Study director, Hospital Moinhos de VentoFlávia R Machado, MD, PhD, Study director, Universidade Federal de São Paulo, UNIFESPRodrigo S Biondi, MD, Study director, Instituto de Cardiologia do Distrito Federal, ICDFFlávio G Rezende de Freitas, MD, PhD, Study director, Universidade Federal de São Paulo, Departamento de Cirurgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875873
- Sponsor's protocol ID
- basics001
- Acronym
- BaSICS
- Status last verified
- Apr 2021
- First submitted
- 15 Aug 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be publicly available two years after trial results have been published
Publications
Zampieri FG, Damiani LP, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Serpa-Neto A, Manoel ALO, Miranda TA, Correa TD, Azevedo LCP, Silva NBD, Machado FR, Cavalcanti AB; BRICNet. Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):410-417. doi: 10.5935/0103-507X.20220261-pt. Epub 2023 Mar 3.
PubMed 36888820Zampieri FG, Damiani LP, Bagshaw SM, Semler MW, Churpek M, Azevedo LCP, Figueiredo RC, Veiga VC, Biondi R, Freitas FR, Machado FR, Cavalcanti AB; BRICNet. Conditional Treatment Effect Analysis of Two Infusion Rates for Fluid Challenges in Critically Ill Patients: A Secondary Analysis of Balanced Solution versus Saline in Intensive Care Study (BaSICS) Trial. Ann Am Thorac Soc. 2023 Jun;20(6):872-879. doi: 10.1513/AnnalsATS.202211-946OC.
PubMed 36735931Zampieri FG, Damiani LP, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Serpa-Neto A, Manoel ALO, Miranda TA, Correa TD, Azevedo LCP, Silva NB, Machado FR, Cavalcanti AB; BRICNet. Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS). J Crit Care. 2022 Oct;71:154113. doi: 10.1016/j.jcrc.2022.154113. Epub 2022 Jul 14.
PubMed 35843046Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Serpa-Neto A, Paranhos JLR, Lucio EA, Oliveira-Junior LC, Lisboa TC, Lacerda FH, Maia IS, Grion CMC, Assuncao MSC, Manoel ALO, Correa TD, Guedes MAVA, Azevedo LCP, Miranda TA, Damiani LP, Brandao da Silva N, Cavalcanti AB. Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults: A Secondary Exploratory Analysis of the BaSICS Clinical Trial. Am J Respir Crit Care Med. 2022 Jun 15;205(12):1419-1428. doi: 10.1164/rccm.202111-2484OC.
PubMed 35349397Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Assuncao MSC, Serpa-Neto A, Paranhos JLR, Andrade J, Godoy MMG, Romano E, Dal Pizzol F, Silva EB, Silva MML, Machado MCV, Malbouisson LMS, Manoel ALO, Thompson MM, Figueiredo LM, Soares RM, Miranda TA, de Lima LM, Santucci EV, Correa TD, Azevedo LCP, Kellum JA, Damiani LP, Silva NB, Cavalcanti AB; BaSICS investigators and the BRICNet members. Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial. JAMA. 2021 Sep 7;326(9):830-838. doi: 10.1001/jama.2021.11444.
PubMed 34547081Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Serpa-Neto A, Paranhos JLR, Guedes MAV, Lucio EA, Oliveira-Junior LC, Lisboa TC, Lacerda FH, Maia IS, Grion CMC, Assuncao MSC, Manoel ALO, Silva-Junior JM, Duarte P, Soares RM, Miranda TA, de Lima LM, Gurgel RM, Paisani DM, Correa TD, Azevedo LCP, Kellum JA, Damiani LP, Brandao da Silva N, Cavalcanti AB; BaSICS investigators and the BRICNet members. Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial. JAMA. 2021 Aug 10;326(9):1-12. doi: 10.1001/jama.2021.11684. Online ahead of print.
PubMed 34375394Zampieri FG, Azevedo LCP, Correa TD, Falavigna M, Machado FR, Assuncao MSC, Lobo SMA, Dourado LK, Berwanger O, Kellum JA, Brandao N, Cavalcanti AB; BaSICS Investigators and the BRICNet. Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial. Crit Care Resusc. 2017 Jun;19(2):175-182.
PubMed 28651514
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Solution Versus Saline in Intensive Care Study
- ClinicalTrials.gov ID
- NCT02875873
- Acronym / sponsor ID
- BaSICS / basics001
- Conditions
- Critical Illness, Acute Kidney Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,075 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 27 May 2017 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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.
A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients
Detailed description
Pragmatic, multicenter, 2x2 factorial randomized study. Severe patients admitted to the ICU at moderate to high risk for death or acute kidney injury will be randomly allocated to receive a balanced crystalloid solution (Plasma-Lyte®) or 0.9% saline and to receive crystalloids by rapid bolus infusion (999 mL/h) or slow infusion (333 mL/h) whenever plasma expansion is needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plasma-Lyte, Slow Infusion | Experimental | Drug: Plasma-Lyte, Other: Slow infusion speedPlasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. |
| Plasma-Lyte, Fast Infusion | Experimental | Drug: Plasma-Lyte, Other: Fast Infusion SpeedPlasma-Lyte will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. |
| Saline 0.9%, Slow Infusion | Experimental | Drug: Saline 0.9%, Other: Slow infusion speedSaline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. |
| Saline 0.9%, Fast Infusion | Experimental | Drug: Saline 0.9%, Other: Fast Infusion SpeedSaline 0.9% will be used for fluid expansion and maintenance whenever needed and when there is no contraindication either for Plasma-Lyte or normal saline. Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Need for plasma expansion, and the clinician considers that Plasma-Lyte® or 0.9% saline are equally appropriate for patients, with no specific indications or contraindications for any of the fluids or for rapid or slow infusion.
- Patients not expected to be discharged on the day after their admission.
- At least one of the following risk factors for acute renal injury:
Key exclusion criteria (8 listed)
- Age < 18 years
- Acute renal failure treated with renal replacement therapy (RRT) or expected to require RRT within the next 6 hours
- Severe hyponatremia (serum sodium ≤ 120 mmol/L)
- Severe hypernatremia (serum sodium ≥ 160 mmol/L)
- Death considered imminent and inevitable within 24 hours
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 |
|---|---|---|
| Plasma-LytePlasma-Lyte will be used for fluid expansion and maintenance | Drug | Plasma-Lyte, Fast Infusion, Plasma-Lyte, Slow Infusion |
| Saline 0.9%Also: Normal SalineSaline 0.9% will be used for fluid expansion and maintenance | Drug | Saline 0.9%, Fast Infusion, Saline 0.9%, Slow Infusion |
| Slow infusion speedWhenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. NOTE: This intervention will not be blinded. | Other | Plasma-Lyte, Slow Infusion, Saline 0.9%, Slow Infusion |
| Fast Infusion SpeedWhenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. NOTE: This intervention will not be blinded. | Other | Plasma-Lyte, Fast Infusion, Saline 0.9%, Fast Infusion |
Primary outcome
Mortality
Time frame: 90 days
4 secondary outcomes
Renal failure requiring renal replacement therapy
Time frame: 90 days
Renal Injury (KDIGO equal or greater than 2)
Time frame: Days 3 and 7
Hepatic, cardiac, neurological, coagulation, and respiratory dysfunctions (assessed by Sequential Organ Failure Assessment [SOFA] scores)
Time frame: Days 3 and 7
Mechanical ventilation free days
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 36888820Zampieri FG, Damiani LP, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Serpa-Neto A, Manoel ALO, Miranda TA, Correa TD, Azevedo LCP, Silva NBD, Machado FR, Cavalcanti AB; BRICNet. Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):410-417. doi: 10.5935/0103-507X.20220261-pt. Epub 2023 Mar 3.
- Derived from this study: PubMed 36735931Zampieri FG, Damiani LP, Bagshaw SM, Semler MW, Churpek M, Azevedo LCP, Figueiredo RC, Veiga VC, Biondi R, Freitas FR, Machado FR, Cavalcanti AB; BRICNet. Conditional Treatment Effect Analysis of Two Infusion Rates for Fluid Challenges in Critically Ill Patients: A Secondary Analysis of Balanced Solution versus Saline in Intensive Care Study (BaSICS) Trial. Ann Am Thorac Soc. 2023 Jun;20(6):872-879. doi: 10.1513/AnnalsATS.202211-946OC.
- Derived from this study: PubMed 35843046Zampieri FG, Damiani LP, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Serpa-Neto A, Manoel ALO, Miranda TA, Correa TD, Azevedo LCP, Silva NB, Machado FR, Cavalcanti AB; BRICNet. Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS). J Crit Care. 2022 Oct;71:154113. doi: 10.1016/j.jcrc.2022.154113. Epub 2022 Jul 14.
- Derived from this study: PubMed 35349397Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Serpa-Neto A, Paranhos JLR, Lucio EA, Oliveira-Junior LC, Lisboa TC, Lacerda FH, Maia IS, Grion CMC, Assuncao MSC, Manoel ALO, Correa TD, Guedes MAVA, Azevedo LCP, Miranda TA, Damiani LP, Brandao da Silva N, Cavalcanti AB. Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults: A Secondary Exploratory Analysis of the BaSICS Clinical Trial. Am J Respir Crit Care Med. 2022 Jun 15;205(12):1419-1428. doi: 10.1164/rccm.202111-2484OC.
- Derived from this study: PubMed 34547081Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Assuncao MSC, Serpa-Neto A, Paranhos JLR, Andrade J, Godoy MMG, Romano E, Dal Pizzol F, Silva EB, Silva MML, Machado MCV, Malbouisson LMS, Manoel ALO, Thompson MM, Figueiredo LM, Soares RM, Miranda TA, de Lima LM, Santucci EV, Correa TD, Azevedo LCP, Kellum JA, Damiani LP, Silva NB, Cavalcanti AB; BaSICS investigators and the BRICNet members. Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial. JAMA. 2021 Sep 7;326(9):830-838. doi: 10.1001/jama.2021.11444.
- Derived from this study: PubMed 34375394Zampieri FG, Machado FR, Biondi RS, Freitas FGR, Veiga VC, Figueiredo RC, Lovato WJ, Amendola CP, Serpa-Neto A, Paranhos JLR, Guedes MAV, Lucio EA, Oliveira-Junior LC, Lisboa TC, Lacerda FH, Maia IS, Grion CMC, Assuncao MSC, Manoel ALO, Silva-Junior JM, Duarte P, Soares RM, Miranda TA, de Lima LM, Gurgel RM, Paisani DM, Correa TD, Azevedo LCP, Kellum JA, Damiani LP, Brandao da Silva N, Cavalcanti AB; BaSICS investigators and the BRICNet members. Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial. JAMA. 2021 Aug 10;326(9):1-12. doi: 10.1001/jama.2021.11684. Online ahead of print.
- Derived from this study: PubMed 28651514Zampieri FG, Azevedo LCP, Correa TD, Falavigna M, Machado FR, Assuncao MSC, Lobo SMA, Dourado LK, Berwanger O, Kellum JA, Brandao N, Cavalcanti AB; BaSICS Investigators and the BRICNet. Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial. Crit Care Resusc. 2017 Jun;19(2):175-182.
- Individual participant dataSharing planned: Yes. Data will be publicly available two years after trial results have been published
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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.
Alexandre B Cavalcanti, MD, PhD study chair
Hospital do Coracao
Fernando G Zampieri, MD principal investigator
Hospital do Coracao
Nilton Brandao, MD, PhD study director
Hospital Moinhos de Vento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plasma-Lyte, Saline 0.9% and Slow infusion speed in people with Critical Illness and Acute Kidney Injury, run by Hospital do Coracao at 1 site in Brazil.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 19 Apr 2021. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 90 days). 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 NCT02875873, which also lists 7 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 19 Apr 2021.