Cardiac Surgery Associated - Acute Kidney InjurySAFEGUARDNCT07123935
Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury
A study testing RenalGuard® Therapy in people with Cardiac Surgery Associated - Acute Kidney Injury and AKI - Acute Kidney Injury, run by CardioRenal Systems, Inc. at 2 sites in Malaysia.
Trial summary
The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Associated - Acute Kidney Injury, AKI - Acute Kidney Injury
- What is being tested?
- RenalGuard® Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female and >18 years old.
- Patient able to give written consent.
- Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination:
- coronary artery bypass graft (CABG)
- aortic valve replacement or repair alone, with or without aortic root repair
- mitral, tricuspid, or pulmonic valve replacement or repair
Show all 20Show fewer
- simultaneous replacement of several cardiac valves
- CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- Surgery on the aorta: aortic root and/ or ascending aorta
- AF ablation surgery if combined with other cardiac procedures.
- ASD closure if combined with other cardiac procedures.
- Excision of myxoma if combined with other cardiac procedures
- Have at least one of the following risk factors for CSA-AKI:
- CKD-EPI eGFR 20-59 mL/min/1.73 m²
- Undergoing combined surgery (e.g. CABG + Valve)
- STS Score ≥4 or Logistic EuroScore of ≥5 or, Euroscore II of ≥4
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Insulin-requiring diabetes
- Non-insulin-requiring diabetes with HbA1C ≥ 6.1% in the last 6 months
- Preoperative anemia (hemoglobin ≤11g/dl for men and women) within 4 weeks of surgery
Who cannot join
- Patient requiring emergency surgery
- Surgery to be performed without CPB
- Patient receiving furosemide at a dose>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
- Patient who cannot be urethrally catheterize for any reason
- Patients already dialysis dependent
- Patients with CKD-EPI eGFR <20 mL/min/1.73 m²
Show all 19Show fewer
- Known or suspected AKI (KDIGO criteria) at the time of screening
- IV contrast within 48 hours of surgery
- Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days
- Pregnant patient, self-reported
- Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature < 28°Celsius (82.4° Fahrenheit)
- Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission
- Patients with pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious aetiology reported on chest x-ray or CT scan in the last 7 days
- Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella, IABP) within 24 hours prior to surgery
- Patients on extracorporeal membrane oxygenation (ECMO) or durable ventricular assist device (VAD) at the time of screening, or planned use within 24h prior to surgery
- Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function.
- Patient underwent prior solid organ transplantation
- Patients underwent major surgery within the last 3 months
- Any condition which, in the judgement of the investigator, might increase the risk to the patient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites
Institut Jantung Negara
Kuala Lumpur
Krishna Moorthy Dr. Paneer Selvam, +6012 309 6045, paneer@ijn.com.my
Krishna Moorthy Dr. Paneer Selvam
Universiti Malaya Medical Centre
Kuala Lumpur
Krishnasamy Professor Dr. Sivakumar, +6017 345 3839, sivakumar@um.edu.my
Len Dr. En Yean
About this study
Official title: Assessing the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) - SAFEGUARD Study
The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC).
The study is planned to be conducted in 2 clinical sites in the Malaysia - Universiti Malaya Medical Centre and Institut Jantung Negara, Kuala Lumpur, Malaysia.
Read more
Participants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines.
For both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery.
Patients will be followed up for up to 7 days post surgery or until discharge, which ever comes first.
Long-term follow up will be performed at 90 days post surgery.
- Being tested
- RenalGuard® Therapy, Standard of Care (SOC)
- Keywords
- acute kidney injury, cardiac surgery, RenalGuard Therapy, matched enhanced diuresis
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenalGuard® TherapyDevice
RenalGuard Therapy®
Standard of Care (SOC)Other
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Current Standard of Care Receives: Other: Standard of Care (SOC) |
| Study Group | Active comparator | Patient with RenalGuard® Therapy Receives: Device: RenalGuard® Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) occurring within 72 hours following surgery in the RenalGuard versus Control group
Rate of CSA-AKI as defined by the KDIGO definition i.e. as when any one of the following three criteria are met:
- An increase in serum creatinine (SCr) by ≥0.3 mg/dl (≥26.5 umol/l) within 72 hours compared to the baseline value; OR
- An increase in SCr by ≥1.5 times from SCr value at baseline within 72 hours; OR
- Use of Renal Replacement Therapy (RRT) within 7 days of surgery or by hospital discharge
Measured: Within 72 hours
Secondary outcomes (1)
AKI severity as defined by KDIGO stage definition, with stage distribution between the study groups at 72 hours post-surgery AKI stage
The staging of AKI (KDIGO) is based on the following criteria:
Stage 1 Increase ≥ 26 μmol/L within 72 hrs or Increase 1.5 to 1.9 times from baseline
Stage 2 Increase 2 to 2.9 x reference creatinine
Stage 3 Increase ≥3 X reference creatinine or increase 354 μmol/L or need for RRT
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (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 Cardiac Surgery Associated - Acute Kidney InjuryStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioRenal Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Malaya, Institut Jantung Negara
- Responsible party
- Sponsor
- Investigators
- Krishnasamy Professor Dr. Sivakumar, Principal investigator, Universiti Malaya Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123935
- Sponsor's protocol ID
- RG-CSA-AKI-Malaysia-003
- Acronym
- SAFEGUARD
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, information regarding the protocol and statistical analysis plan will be shared on request. Additionally anonymised data will be available upon reasonable request.
Publications
Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
PubMed 33236105Redfors B, Bragadottir G, Sellgren J, Sward K, Ricksten SE. Effects of norepinephrine on renal perfusion, filtration and oxygenation in vasodilatory shock and acute kidney injury. Intensive Care Med. 2011 Jan;37(1):60-7. doi: 10.1007/s00134-010-2057-4. Epub 2010 Oct 15.
PubMed 20949349Brown JK, Shaw AD, Mythen MG, Guzzi L, Reddy VS, Crisafi C, Engelman DT; PeriOperative Quality Initiative and the Enhanced Recovery After Surgery Cardiac Workgroup. Adult Cardiac Surgery-Associated Acute Kidney Injury: Joint Consensus Report. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1579-1590. doi: 10.1053/j.jvca.2023.05.032. Epub 2023 May 23.
PubMed 37355415Luckraz H, Giri R, Wrigley B, Hennessy AM, Nicholas J, Nevill A. The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study. Open Heart. 2017 Oct 10;4(2):e000669. doi: 10.1136/openhrt-2017-000669. eCollection 2017.
PubMed 29071091Lau D, Pannu N, James MT, Hemmelgarn BR, Kieser TM, Meyer SR, Klarenbach S. Costs and consequences of acute kidney injury after cardiac surgery: A cohort study. J Thorac Cardiovasc Surg. 2021 Sep;162(3):880-887. doi: 10.1016/j.jtcvs.2020.01.101. Epub 2020 Mar 3.
PubMed 32299694Zarbock A, Kullmar M, Ostermann M, Lucchese G, Baig K, Cennamo A, Rajani R, McCorkell S, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima AL, Garcia Alvarez M, Italiano S, Miralles Bagan J, Kunst G, Nair S, L'Acqua C, Hoste E, Vandenberghe W, Honore PM, Kellum JA, Forni LG, Grieshaber P, Massoth C, Weiss R, Gerss J, Wempe C, Meersch M. Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):292-302. doi: 10.1213/ANE.0000000000005458.
PubMed 33684086Mishra PK, Luckraz H, Nandi J, Nevill A, Giri R, Panayiotou A, Nicholas J. Long-term quality of life postacute kidney injury in cardiac surgery patients. Ann Card Anaesth. 2018 Jan-Mar;21(1):41-45. doi: 10.4103/aca.ACA_104_17.
PubMed 29336390Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0.
PubMed 30135570
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) - SAFEGUARD Study
- ClinicalTrials.gov ID
- NCT07123935
- Acronym / sponsor ID
- SAFEGUARD / RG-CSA-AKI-Malaysia-003
- Keywords
- acute kidney injury, cardiac surgery, RenalGuard Therapy, matched enhanced diuresis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CardioRenal Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Malaya, Institut Jantung Negara
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Aug 2025 (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 of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC).
The study is planned to be conducted in 2 clinical sites in the Malaysia - Universiti Malaya Medical Centre and Institut Jantung Negara, Kuala Lumpur, Malaysia.
Participants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines.
For both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery.
Patients will be followed up for up to 7 days post surgery or until discharge, which ever comes first.
Long-term follow up will be performed at 90 days post surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Standard of Care (SOC)Current Standard of Care |
| Study Group | Active comparator | Device: RenalGuard® TherapyPatient with RenalGuard® Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female and >18 years old.
- Patient able to give written consent.
- Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination:
- Have at least one of the following risk factors for CSA-AKI:
Key exclusion criteria (19 listed)
- Patient requiring emergency surgery
- Surgery to be performed without CPB
- Patient receiving furosemide at a dose>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
- Patient who cannot be urethrally catheterize for any reason
- Patients already dialysis dependent
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 |
|---|---|---|
| RenalGuard® TherapyRenalGuard Therapy® | Device | Study Group |
| Standard of Care (SOC)Standard of care | Other | Control |
Primary outcome
Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) occurring within 72 hours following surgery in the RenalGuard versus Control group
Time frame: Within 72 hours
Rate of CSA-AKI as defined by the KDIGO definition i.e. as when any one of the following three criteria are met: 1. An increase in serum creatinine (SCr) by ≥0.3 mg/dl (≥26.5 umol/l) within 72 hours compared to the baseline value; OR 2. An increase in SCr by ≥1.5 times from SCr value at baseline within 72 hours; OR 3. Use of Renal Replacement Therapy (RRT) within 7 days of surgery or by hospital discharge
1 secondary outcome
AKI severity as defined by KDIGO stage definition, with stage distribution between the study groups at 72 hours post-surgery AKI stage
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 33236105Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
- Background: PubMed 20949349Redfors B, Bragadottir G, Sellgren J, Sward K, Ricksten SE. Effects of norepinephrine on renal perfusion, filtration and oxygenation in vasodilatory shock and acute kidney injury. Intensive Care Med. 2011 Jan;37(1):60-7. doi: 10.1007/s00134-010-2057-4. Epub 2010 Oct 15.
- Background: PubMed 37355415Brown JK, Shaw AD, Mythen MG, Guzzi L, Reddy VS, Crisafi C, Engelman DT; PeriOperative Quality Initiative and the Enhanced Recovery After Surgery Cardiac Workgroup. Adult Cardiac Surgery-Associated Acute Kidney Injury: Joint Consensus Report. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1579-1590. doi: 10.1053/j.jvca.2023.05.032. Epub 2023 May 23.
- Background: PubMed 29071091Luckraz H, Giri R, Wrigley B, Hennessy AM, Nicholas J, Nevill A. The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study. Open Heart. 2017 Oct 10;4(2):e000669. doi: 10.1136/openhrt-2017-000669. eCollection 2017.
- Background: PubMed 32299694Lau D, Pannu N, James MT, Hemmelgarn BR, Kieser TM, Meyer SR, Klarenbach S. Costs and consequences of acute kidney injury after cardiac surgery: A cohort study. J Thorac Cardiovasc Surg. 2021 Sep;162(3):880-887. doi: 10.1016/j.jtcvs.2020.01.101. Epub 2020 Mar 3.
- Background: PubMed 33684086Zarbock A, Kullmar M, Ostermann M, Lucchese G, Baig K, Cennamo A, Rajani R, McCorkell S, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima AL, Garcia Alvarez M, Italiano S, Miralles Bagan J, Kunst G, Nair S, L'Acqua C, Hoste E, Vandenberghe W, Honore PM, Kellum JA, Forni LG, Grieshaber P, Massoth C, Weiss R, Gerss J, Wempe C, Meersch M. Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):292-302. doi: 10.1213/ANE.0000000000005458.
- Background: PubMed 29336390Mishra PK, Luckraz H, Nandi J, Nevill A, Giri R, Panayiotou A, Nicholas J. Long-term quality of life postacute kidney injury in cardiac surgery patients. Ann Card Anaesth. 2018 Jan-Mar;21(1):41-45. doi: 10.4103/aca.ACA_104_17.
- Background: PubMed 30135570Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After completion of the study, information regarding the protocol and statistical analysis plan will be shared on request. Additionally anonymised data will be available upon reasonable request.
Related trials for Cardiac Surgery Associated - Acute Kidney Injury
Recruiting
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Cardiac Surgery-associated Acute Kidney Injury
Active, not recruitingObservational study
Establishment of a Perioperative Dynamic Prediction Model for Cardiac Surgery-associated Acute Kidney Injury
CSA-AKI, Acute Kidney Injury
Not yet recruitingObservational study
Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury
Acute Kidney Injury, Cardiac Surgery Associated - Acute Kidney Injury
Not yet recruitingObservational study
Development and Validation of a Risk Prediction Model for Cardiac Surgery-associated Acute Kidney Injury Based on the Gut-Kidney Axis, Incorporating Gut Microbiota and Their Metabolites
Acute Kidney Injury After Adult Cardiac Surgery, Gastrointestinal Microbiome
Not yet recruitingPhase 2
Terbinafine for CSA-AKI Prevention
Acute Kidney Injury, Cardiac Surgical Procedures
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.
Krishnasamy Professor Dr. Sivakumar principal investigator
Universiti Malaya Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RenalGuard® Therapy in people with Cardiac Surgery Associated - Acute Kidney Injury and AKI - Acute Kidney Injury, run by CardioRenal Systems, Inc. at 2 sites in Malaysia.
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 20 inclusion and 19 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: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krishnasamy Professor Dr. Sivakumar (+6017 345 3839, sivakumar@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) occurring within 72 hours following surgery in the RenalGuard versus Control group (time frame: Within 72 hours). 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 NCT07123935, 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 14 Aug 2025.