Postoperative ComplicationsEXCARENCT04187664
Extended Care in High-Risk Surgical Patient (EXCARE) Pathway in High-risk Surgical Population
A study testing Postoperative Monitoring and High-sensitivity cardiac troponin testing in people with Postoperative Complications and Patient Care Team, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
High risk surgical patients are subject to complications that impact rehabilitation time, overall mortality and costs. This project proposes the creation of a post-surgery care pathway called Extended Care in High-Risk Surgical Patients (EXCARE) in the form of coordinated multiprofessional actions dedicated to… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Postoperative Complications, Patient Care Team
- What is being tested?
- Postoperative Monitoring and High-sensitivity cardiac troponin testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,720 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2019to 31 Jul 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age over 16 years;
- Classified as high-risk by the SAMPE Risk Model (30-day mortality >5%);
- Underwent non-cardiac surgeries at the main operating room unit;
- Referred postoperatively to the postanesthesia care unit or intensive care unit.
Who cannot join
- Patients undergoing procedures performed outside the operating room unit (outpatient, diagnostic, performed under local anesthesia);
- Patients undergoing cardiac surgery with cardiopulmonary bypass and / or referred to the cardiac ICU postoperatively;
- Patients undergoing organ transplantation;
- Low-risk patients (classified as <5% probability of death within 30 days by the SAMPE Risk Model).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035007
Luciana Cadore Stefani, PhD, +555133598226, lpstefani@hcpa.edu.br
Luciana Cadore Stefani, PhD
About this study
Official title: Implementation of the Extended Care in High-Risk Surgical Patient (EXCARE) Pathway in High-risk Non-cardiac Surgical Population: Impact on Morbidity and 30-day Mortality
High risk surgical patients are subject to complications that impact rehabilitation time, overall mortality and costs. This project proposes the creation of a post-surgery care pathway called Extended Care in High-Risk Surgical Patients (EXCARE) in the form of coordinated multiprofessional actions dedicated to high-risk non-cardiac surgical patients with the aim of improving the postoperative outcomes. The proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the Anaesthesia and Perioperative Medicine Service (SAMPE) Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units (ICU), and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams.
This is a quasi-experiment in which the clinical effectiveness of the extended care will be analyzed using a before-and-after comparison, the primary outcome being 30-day surgical mortality and postoperative complications at day 7 defined by PostOperative Morbidity Survey (POMS), a reliable and valid survey of short-term postoperative morbidity in major elective surgery. POMS domains evaluated are: pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological and wound complications.
Secondary outcomes include 30-day mortality, hospital length of stay, number of Rapid Response Team calls, unplanned postoperative ICU admission, surgical reintervention, failure to rescue and hospital readmission. High-sensitive cardiac troponin (hs-cTn) levels will be measured before surgery and daily until 48 hours postoperatively to identify patients with myocardial injury (defined as any hs-cTn concentration greater than the 99th-percentile upper reference limit).
Read the detailed description
Study Strengths and Limitations: This is the first study to evaluate the implementation of surgical patient stratification using the SAMPE Risk Model, pioneering the creation of a multidisciplinary care pathway that involves nursing and medical teams, and can be consolidated as a future standard of assistance. The care bundle, using an objective risk communication tool, is expected to integrate the teams involved in the perioperative care, reducing the fragmentation of care and, consequently, postoperative complications. The study is designed to use historical controls (before and after) and is therefore inherently vulnerable to the biases of this design. It will be conducted in a single teaching hospital and referral centre that provides care to patients from across southern Brazil through the national unified health system centre, which can therefore limit its external validity.
- Conditions
- Postoperative Complications, Patient Care Team
- Being tested
- Postoperative Monitoring, High-sensitivity cardiac troponin testing
- Keywords
- failure to rescue, high-risk surgical patient
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative MonitoringBehavioural
Nursing and medical staff will monitor patients vital signs and clinical deterioration triggers twice as often as in previous ward care.
High-sensitivity cardiac troponin testingDiagnostic test
High-risk patients will have their high-sensitivity cardiac troponin tested preoperatively and daily for the first 48h postoperatively
| Study group | Role | What they receive |
|---|---|---|
| EXCARE Pathway Group | Experimental | The proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the SAMPE Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units, and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams. Receives: Behavioral: Postoperative Monitoring; Diagnostic Test: High-sensitivity cardiac troponin testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality within 30 days
Measured: 30 days
Postoperative complications
Postoperative complications within 7-days defined by Post-operative Morbidity Survey (POMS) domains
Measured: 7 days
Secondary outcomes (7)
Length of stay (LOS)
Hospital length of stay (days)
Measured: 6 months
Unplanned intensive care unit (ICU) admission
Admission to ICU due to clinical deterioration within 30 days
Measured: 30 days
Calls to rapid response team (RRT)
Number of calls to the RRT within 30 days
Measured: 30 days
Surgical reintervention
Number of surgical reinterventions within 30 days
Measured: 30 days
Hospital readmission
Hospital readmission within 30 days
Measured: 30 days
Failure to rescue
Death after a treatable complication within 30 days
Measured: 30 days
High-sensitivity cardiac troponin levels
High-sensitivity cardiac troponin (hs-cTn) elevation due to myocardial injury (defined as any hs-cTn concentration greater than the 99th-percentile upper reference limit.) 3 categories:
- Acute myocardial injury due to myocardial infarction (requires at least 1 of the following: symptoms of myocardial ischemia, new ischemic electrocardiographic changes, new ischemic regional wall-motion abnormalities on cardiac imaging, and/or an acute coronary thrombus on coronary angiography) or nonischemic causes (documented nonischemic etiology);
- Myocardial Injury After Noncardiac Surgery (MINS): myocardial injury caused by ischemia (that may or may not result in necrosis), has prognostic relevance and occurs during or within 30 days after noncardiac surgery.
- Chronic myocardial injury: stable but elevated troponin.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start30 Jan 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental study, nonrandomized, pre-post intervention study
- Masking
- None (open label)
- Enrolment
- 1,720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciana Cadore Stefani, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187664
- Sponsor's protocol ID
- 2019-0066
- Acronym
- EXCARE
- Status last verified
- Jun 2020
- First submitted
- 3 Dec 2019
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stefani LC, Gutierrez CS, Castro SMJ, Zimmer RL, Diehl FP, Meyer LE, Caumo W. Derivation and validation of a preoperative risk model for postoperative mortality (SAMPE model): An approach to care stratification. PLoS One. 2017 Oct 30;12(10):e0187122. doi: 10.1371/journal.pone.0187122. eCollection 2017.
PubMed 29084236Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
PubMed 28444280Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
PubMed 22998715Ferraris VA, Bolanos M, Martin JT, Mahan A, Saha SP. Identification of patients with postoperative complications who are at risk for failure to rescue. JAMA Surg. 2014 Nov;149(11):1103-8. doi: 10.1001/jamasurg.2014.1338.
PubMed 25188264Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
PubMed 10439777Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Neto PCDS, Castro SMJ, Stefani LC. Postoperative intensive care allocation and mortality in high-risk surgical patients: evidence from a low- and middle-income country cohort. Braz J Anesthesiol. 2024 Jul-Aug;74(4):844517. doi: 10.1016/j.bjane.2024.844517. Epub 2024 May 23.
PubMed 38789003Stahlschmidt A, Passos SC, Dornelles DD, Polanczyk C, Gutierrez CS, Minuzzi RR, Castro SMJ, Stefani LC; and the Ex-Care Collaborative. Troponin elevation as a marker of short deterioration and one-year death in a high-risk surgical patient cohort in a low and middle income country setting: a postoperative approach to increase surveillance. Can J Anaesth. 2023 Nov;70(11):1776-1788. doi: 10.1007/s12630-023-02558-4. Epub 2023 Oct 18.
PubMed 37853279Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Gutierrez CS, Castro SMJ, Caumo W, Pearse RM; Ex-Care collaborative; Stefani LC. Enhanced peri-operative care to improve outcomes for high-risk surgical patients in Brazil: a single-centre before-and-after cohort study. Anaesthesia. 2022 Apr;77(4):416-427. doi: 10.1111/anae.15671. Epub 2022 Feb 15.
PubMed 35167136
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Extended Care in High-Risk Surgical Patient (EXCARE) Pathway in High-risk Non-cardiac Surgical Population: Impact on Morbidity and 30-day Mortality
- ClinicalTrials.gov ID
- NCT04187664
- Acronym / sponsor ID
- EXCARE / 2019-0066
- Conditions
- Postoperative Complications, Patient Care Team
- Keywords
- failure to rescue, high-risk surgical patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,720 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 5 Dec 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.
High risk surgical patients are subject to complications that impact rehabilitation time, overall mortality and costs. This project proposes the creation of a post-surgery care pathway called Extended Care in High-Risk Surgical Patients (EXCARE) in the form of coordinated multiprofessional actions dedicated to high-risk non-cardiac surgical patients with the aim of improving the postoperative outcomes. The proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the Anaesthesia and Perioperative Medicine Service (SAMPE) Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units (ICU), and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams.
This is a quasi-experiment in which the clinical effectiveness of the extended care will be analyzed using a before-and-after comparison, the primary outcome being 30-day surgical mortality and postoperative complications at day 7 defined by PostOperative Morbidity Survey (POMS), a reliable and valid survey of short-term postoperative morbidity in major elective surgery. POMS domains evaluated are: pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological and wound complications.
Secondary outcomes include 30-day mortality, hospital length of stay, number of Rapid Response Team calls, unplanned postoperative ICU admission, surgical reintervention, failure to rescue and hospital readmission. High-sensitive cardiac troponin (hs-cTn) levels will be measured before surgery and daily until 48 hours postoperatively to identify patients with myocardial injury (defined as any hs-cTn concentration greater than the 99th-percentile upper reference limit).
Detailed description
Study Strengths and Limitations: This is the first study to evaluate the implementation of surgical patient stratification using the SAMPE Risk Model, pioneering the creation of a multidisciplinary care pathway that involves nursing and medical teams, and can be consolidated as a future standard of assistance. The care bundle, using an objective risk communication tool, is expected to integrate the teams involved in the perioperative care, reducing the fragmentation of care and, consequently, postoperative complications. The study is designed to use historical controls (before and after) and is therefore inherently vulnerable to the biases of this design. It will be conducted in a single teaching hospital and referral centre that provides care to patients from across southern Brazil through the national unified health system centre, which can therefore limit its external validity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental study, nonrandomized, pre-post intervention study
| Arm | Type | Receives |
|---|---|---|
| EXCARE Pathway Group | Experimental | Behavioral: Postoperative Monitoring, Diagnostic Test: High-sensitivity cardiac troponin testingThe proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the SAMPE Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units, and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 16 years;
- Classified as high-risk by the SAMPE Risk Model (30-day mortality >5%);
- Underwent non-cardiac surgeries at the main operating room unit;
- Referred postoperatively to the postanesthesia care unit or intensive care unit.
Key exclusion criteria (4 listed)
- Patients undergoing procedures performed outside the operating room unit (outpatient, diagnostic, performed under local anesthesia);
- Patients undergoing cardiac surgery with cardiopulmonary bypass and / or referred to the cardiac ICU postoperatively;
- Patients undergoing organ transplantation;
- Low-risk patients (classified as <5% probability of death within 30 days by the SAMPE Risk Model).
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 |
|---|---|---|
| Postoperative MonitoringNursing and medical staff will monitor patients vital signs and clinical deterioration triggers twice as often as in previous ward care. | Behavioural | EXCARE Pathway Group |
| High-sensitivity cardiac troponin testingHigh-risk patients will have their high-sensitivity cardiac troponin tested preoperatively and daily for the first 48h postoperatively | Diagnostic test | EXCARE Pathway Group |
Primary outcome
Mortality
Time frame: 30 days
In-hospital mortality within 30 days
Postoperative complications
Time frame: 7 days
Postoperative complications within 7-days defined by Post-operative Morbidity Survey (POMS) domains
7 secondary outcomes
Length of stay (LOS)
Time frame: 6 months
Unplanned intensive care unit (ICU) admission
Time frame: 30 days
Calls to rapid response team (RRT)
Time frame: 30 days
Surgical reintervention
Time frame: 30 days
Hospital readmission
Time frame: 30 days
Failure to rescue
Time frame: 30 days
High-sensitivity cardiac troponin levels
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Background: PubMed 29084236Stefani LC, Gutierrez CS, Castro SMJ, Zimmer RL, Diehl FP, Meyer LE, Caumo W. Derivation and validation of a preoperative risk model for postoperative mortality (SAMPE model): An approach to care stratification. PLoS One. 2017 Oct 30;12(10):e0187122. doi: 10.1371/journal.pone.0187122. eCollection 2017.
- Background: PubMed 28444280Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
- Background: PubMed 22998715Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
- Background: PubMed 25188264Ferraris VA, Bolanos M, Martin JT, Mahan A, Saha SP. Identification of patients with postoperative complications who are at risk for failure to rescue. JAMA Surg. 2014 Nov;149(11):1103-8. doi: 10.1001/jamasurg.2014.1338.
- Background: PubMed 10439777Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
- Derived from this study: PubMed 38789003Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Neto PCDS, Castro SMJ, Stefani LC. Postoperative intensive care allocation and mortality in high-risk surgical patients: evidence from a low- and middle-income country cohort. Braz J Anesthesiol. 2024 Jul-Aug;74(4):844517. doi: 10.1016/j.bjane.2024.844517. Epub 2024 May 23.
- Derived from this study: PubMed 37853279Stahlschmidt A, Passos SC, Dornelles DD, Polanczyk C, Gutierrez CS, Minuzzi RR, Castro SMJ, Stefani LC; and the Ex-Care Collaborative. Troponin elevation as a marker of short deterioration and one-year death in a high-risk surgical patient cohort in a low and middle income country setting: a postoperative approach to increase surveillance. Can J Anaesth. 2023 Nov;70(11):1776-1788. doi: 10.1007/s12630-023-02558-4. Epub 2023 Oct 18.
- Derived from this study: PubMed 35167136Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Gutierrez CS, Castro SMJ, Caumo W, Pearse RM; Ex-Care collaborative; Stefani LC. Enhanced peri-operative care to improve outcomes for high-risk surgical patients in Brazil: a single-centre before-and-after cohort study. Anaesthesia. 2022 Apr;77(4):416-427. doi: 10.1111/anae.15671. Epub 2022 Feb 15.
- 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.
Luciana Cadore Stefani, PhD study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Monitoring and High-sensitivity cardiac troponin testing in people with Postoperative Complications and Patient Care Team, run by Hospital de Clinicas de Porto Alegre 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 4 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 26 Jun 2020. 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.
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 Luciana Cadore Stefani, PhD (+555133598226, lpstefani@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). 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 NCT04187664, which also lists 8 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 Jun 2020.