Acute Kidney InjuryNCT04865510

Citrate Versus Heparin in Continuous Renal Replacement Therapy :

A study testing Regional citrate anticoagulation in people with Acute Kidney Injury and Citrate, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Kidney Injury, Citrate, Cytokines
What is being tested?: Regional citrate anticoagulation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteThailand
Study dates: 4 Feb 2019to 31 Mar 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

need for CRRT,
no contraindication to CRRT

Who cannot join

patients with previous history of chronic kidney disease (CKD) (baseline serum creatinine > 2 mg/dL (male) or > 1.5 mg/dL (female)
history of renal transplantation
known pregnancy
previous dialysis within 30 days
severe liver disease
end stage heart disease or untreatable malignancy

Show all 14Show fewer

moribund patients with expected survival less than 30 days
previous use of heparin or other anticoagulant, antiplatelet within 7 day except use for deep vein thrombosis
active bleeding at the time of enrollment and/or severe coagulopathy
receiving blood or blood components prior to enrollment
hemoglobin less than 7.5 g/dL and/or platelet count less than 100,000/mm3
previous underlying clotting disorders such as hypercoagulable state
severe malnutrition (Body mass index (BMI ) less than 18)
underwent CRRT for other reasons besides acute kidney injury (AKI)

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
Bangkok, 10300

Other trials in Thailand

About this study

Official title: Citrate Versus Heparin in Continuous Renal Replacement Therapy : Effect on Cardiovascular System and Clot Circuit in Critically Ill Patients

This study is a prospective, multicenter, open-label randomized trial comparing regional citrate anticoagulation (RCA) with heparin-free protocol. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode. The investigators measured hemodynamic changes at certain time points after starting CRRT (0, 6, 12, 24, 48, 72 hr).Levels of inflammatory cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-ɑ) were measured at day 1 and day 3

Read the detailed description

Twenty patients were randomized into heparin group and 11 patients were in citrate group. The cardiac performance were not significantly different between 2 groups at every time point. The inflammatory cytokines declined similarly in both treatment arms. The maximum filter survivial time was longer in a RCA group but not reach statistically significant (44.64±26.56 hr vs p=0.693 in citrate and heparin free group respectively).There was no serious side effects dung both treatment arm even in the group of liver dysfunction patients.

Conditions: Acute Kidney Injury, Citrate, Cytokines, Hemodynamic Responses
Being tested: Regional citrate anticoagulation
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.

Regional citrate anticoagulationProcedure or surgery
Also called Heparin-free
The investigators collected patient's plasma at study start (day 0) and at day 3, 5, 7, 14, 28) .Samples were used to measure inflammatory markers (Il 6, IL 8, IL 10 and TNFα) .
. Markers of dialysis efficiency (BUN, creatinine) and other parameters related to AKI (acid base status, calcium, phosphorus, hemoglobin). The recorded variables also included adverse events, dialysis clotting, hemodynamic status, duration of mechanical ventilation, inotropic support. The hemodynamic parameters were monitored by EV 1000 clinical platform .The investigators measured cardiac performance data, which includes cardiac output (CO), cardiac index (CI), stroke volume (SV), and stroke volume indexes (SVI). Moreover, it also provides information about systemic vascular resistance (SVR). Thus, patient hemodynamic parameters as mentioned above were measured at the following 6 time-point: after the initiation of CRRT (T1), every 6 hours later for 24 hours (T2, T3, T4, T5), and at hour-72 (T6).

Study groups in NCT04865510
Study group	Role	What they receive
Citrate	Active comparator	The RCA group CRRT were performed with Prisma flex or (Baxter Healthcare/Gambro Spain) or Informed machine with citrate pump. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in postdilution mode with ST 150 filter sets. The substitution fluid was Accusol or Prismocal B22 .The dose of dialysis was 20-25 ml/kg/hr with blood flow 150-200 ml/min. Trisodium citrate solution (4%,136mmol/L) was infused into the arterial line prior to the blood pump at a dose of 4 mmol/L of plasma flow. Calcium chloride (5% 340 mmol/L elemental calcium) was infused into the venous return to maintain systemic ionized calcium in the normal range (0.99-1.30 mmol/L) and the targets values for ionized calcium (iCa2+) after the dialysis membrane were 0.25-0.35 mmol/L. The rale of calcium infusion was adjusted in a timely manner based on repeated measurements of calcium concentration Receives: Procedure: Regional citrate anticoagulation
Heparin-free	Placebo comparator	The heparin- free group The circuit was periodically flushed with 50 ml saline via access limb every 30 minutes .When pre-filter pressure started to rise, additional saline flushes would be given. Receives: Procedure: Regional citrate anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac output
cm3/min
Measured: 72 hour
Cardiac index
L/min/m2
Measured: 72 hour
Systemic vascular resistance
mmHg⋅min⋅mL-1
Measured: 72 hour
Systemic vascular resistance index
dynes · sec/cm5/m2
Measured: 72 hour

Secondary outcomes (8)

Filter life span
Hours of filter use
Measured: through study completion,an aveage of 72 hours
Changes of IL-1β
Unit/ml
Measured: day 1,day 3
Changes of IL-6
Unit/ml
Measured: day 1,day 3
Changes of IL-8
Units/ml
Measured: day 1,day 3
Changes of IL-10
Units/mL
Measured: day 1,day 3
Changes of TNF-ɑ
Uniys/mL
Measured: day 1,day 3
Mortality
patient survival
Measured: 28 day
Renal survival
dialysis dependent
Measured: 28 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 201931 Mar 2021

First posted29 Apr 2021
Study start4 Feb 2019
Primary completion15 Jan 2021
Study completion31 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for 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: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: This study is a prospective,multicenter, open-label randomized trial
Masking: Single blind
Who is masked: Care provider
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04865510
Sponsor's protocol ID: COA033/61
Status last verified: Apr 2021
First submitted: 22 Apr 2021
Last updated: 29 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Oudemans-van Straaten HM, Kellum JA, Bellomo R. Clinical review: anticoagulation for continuous renal replacement therapy--heparin or citrate? Crit Care. 2011 Jan 24;15(1):202. doi: 10.1186/cc9358.
PubMed 21345279
Gatward JJ, Gibbon GJ, Wrathall G, Padkin A. Renal replacement therapy for acute renal failure: a survey of practice in adult intensive care units in the United Kingdom. Anaesthesia. 2008 Sep;63(9):959-66. doi: 10.1111/j.1365-2044.2008.05514.x. Epub 2008 Jun 28.
PubMed 18549413
Borg R, Ugboma D, Walker DM, Partridge R. Evaluating the safety and efficacy of regional citrate compared to systemic heparin as anticoagulation for continuous renal replacement therapy in critically ill patients: A service evaluation following a change in practice. J Intensive Care Soc. 2017 Aug;18(3):184-192. doi: 10.1177/1751143717695835. Epub 2017 Mar 14.
PubMed 29118829
Cutts MW, Thomas AN, Kishen R. Transfusion requirements during continuous veno-venous haemofiltration: -the importance of filter life. Intensive Care Med. 2000 Nov;26(11):1694-7. doi: 10.1007/s001340000676.
PubMed 11193279
Morabito S, Pistolesi V, Tritapepe L, Fiaccadori E. Regional citrate anticoagulation for RRTs in critically ill patients with AKI. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2173-88. doi: 10.2215/CJN.01280214. Epub 2014 Jul 3.
PubMed 24993448
Tuerdi B, Zuo L, Sun H, Wang K, Wang Z, Li G. Safety and efficacy of regional citrate anticoagulation in continuous blood purification treatment of patients with multiple organ dysfunction syndrome. Braz J Med Biol Res. 2017 Nov 17;51(1):e6378. doi: 10.1590/1414-431X20176378.
PubMed 29185591
Schrezenmeier EV, Barasch J, Budde K, Westhoff T, Schmidt-Ott KM. Biomarkers in acute kidney injury - pathophysiological basis and clinical performance. Acta Physiol (Oxf). 2017 Mar;219(3):554-572. doi: 10.1111/apha.12764. Epub 2016 Aug 25.
PubMed 27474473
Kwon O, Molitoris BA, Pescovitz M, Kelly KJ. Urinary actin, interleukin-6, and interleukin-8 may predict sustained ARF after ischemic injury in renal allografts. Am J Kidney Dis. 2003 May;41(5):1074-87. doi: 10.1016/s0272-6386(03)00206-3.
PubMed 12722043
Liangos O, Kolyada A, Tighiouart H, Perianayagam MC, Wald R, Jaber BL. Interleukin-8 and acute kidney injury following cardiopulmonary bypass: a prospective cohort study. Nephron Clin Pract. 2009;113(3):c148-54. doi: 10.1159/000232595. Epub 2009 Aug 12.
PubMed 19672112
de Fontnouvelle CA, Greenberg JH, Thiessen-Philbrook HR, Zappitelli M, Roth J, Kerr KF, Devarajan P, Shlipak M, Coca S, Parikh CR; TRIBE-AKI Consortium. Interleukin-8 and Tumor Necrosis Factor Predict Acute Kidney Injury After Pediatric Cardiac Surgery. Ann Thorac Surg. 2017 Dec;104(6):2072-2079. doi: 10.1016/j.athoracsur.2017.04.038. Epub 2017 Aug 16.
PubMed 28821332
Trakarnvanich T, Sirivongrangson P, Trongtrakul K, Srisawat N. The effect of citrate in cardiovascular system and clot circuit in critically ill patients requiring continuous renal replacement therapy. J Artif Organs. 2023 Mar;26(1):53-64. doi: 10.1007/s10047-022-01329-0. Epub 2022 Apr 12.
PubMed 35412099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis

All Acute Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Citrate Versus Heparin in Continuous Renal Replacement Therapy : Effect on Cardiovascular System and Clot Circuit in Critically Ill Patients
ClinicalTrials.gov ID: NCT04865510
Acronym / sponsor ID: COA033/61
Conditions: Acute Kidney Injury, Citrate, Cytokines, Hemodynamic Responses
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
Collaborators: King Chulalongkorn Memorial Hospital, Chiang Mai University, Department of Medicine, Somdech Phra Pinklao Hospital, Bangkok, Thailand.
Study start: 4 Feb 2019 (actual)
Primary completion: 15 Jan 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 29 Apr 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (care provider)
Number of arms: 2
Model description: This study is a prospective,multicenter, open-label randomized trial

Arm	Type	Receives
Citrate	Active comparator	Procedure: Regional citrate anticoagulationThe RCA group CRRT were performed with Prisma flex or (Baxter Healthcare/Gambro Spain) or Informed machine with citrate pump. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in postdilution mode with ST 150 filter sets. The substitution fluid was Accusol or Prismocal B22 .The dose of dialysis was 20-25 ml/kg/hr with blood flow 150-200 ml/min. Trisodium citrate solution (4%,136mmol/L) was infused into the arterial line prior to the blood pump at a dose of 4 mmol/L of plasma flow. Calcium chloride (5% 340 mmol/L elemental calcium) was infused into the venous return to maintain systemic ionized calcium in the normal range (0.99-1.30 mmol/L) and the targets values for ionized calcium (iCa2+) after the dialysis membrane were 0.25-0.35 mmol/L. The rale of calcium infusion was adjusted in a timely manner based on repeated measurements of calcium concentration
Heparin-free	Placebo comparator	Procedure: Regional citrate anticoagulationThe heparin- free group The circuit was periodically flushed with 50 ml saline via access limb every 30 minutes .When pre-filter pressure started to rise, additional saline flushes would be given.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

need for CRRT,
no contraindication to CRRT

Key exclusion criteria (14 listed)

patients with previous history of chronic kidney disease (CKD) (baseline serum creatinine > 2 mg/dL (male) or > 1.5 mg/dL (female)
history of renal transplantation
known pregnancy
previous dialysis within 30 days
severe liver disease

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
Regional citrate anticoagulationAlso: Heparin-freeThe investigators collected patient's plasma at study start (day 0) and at day 3, 5, 7, 14, 28) .Samples were used to measure inflammatory markers (Il 6, IL 8, IL 10 and TNFα) . . Markers of dialysis efficiency (BUN, creatinine) and other parameters related to AKI (acid base status, calcium, phosphorus, hemoglobin). The recorded variables also included adverse events, dialysis clotting, hemodynamic status, duration of mechanical ventilation, inotropic support. The hemodynamic parameters were monitored by EV 1000 clinical platform .The investigators measured cardiac performance data, which includes cardiac output (CO), cardiac index (CI), stroke volume (SV), and stroke volume indexes (SVI). Moreover, it also provides information about systemic vascular resistance (SVR). Thus, patient hemodynamic parameters as mentioned above were measured at the following 6 time-point: after the initiation of CRRT (T1), every 6 hours later for 24 hours (T2, T3, T4, T5), and at hour-72 (T6).	Procedure or surgery	Citrate, Heparin-free

Primary outcome

Cardiac output
Time frame: 72 hour
cm3/min
Cardiac index
Time frame: 72 hour
L/min/m2
Systemic vascular resistance
Time frame: 72 hour
mmHg⋅min⋅mL-1
Systemic vascular resistance index
Time frame: 72 hour
dynes · sec/cm5/m2

8 secondary outcomes

Filter life span
Time frame: through study completion,an aveage of 72 hours
Changes of IL-1β
Time frame: day 1,day 3
Changes of IL-6
Time frame: day 1,day 3
Changes of IL-8
Time frame: day 1,day 3
Changes of IL-10
Time frame: day 1,day 3
Changes of TNF-ɑ
Time frame: day 1,day 3
Mortality
Time frame: 28 day
Renal survival
Time frame: 28 day

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 29 Apr 2021.
Results publication: PubMed 21345279Oudemans-van Straaten HM, Kellum JA, Bellomo R. Clinical review: anticoagulation for continuous renal replacement therapy--heparin or citrate? Crit Care. 2011 Jan 24;15(1):202. doi: 10.1186/cc9358.
Results publication: PubMed 18549413Gatward JJ, Gibbon GJ, Wrathall G, Padkin A. Renal replacement therapy for acute renal failure: a survey of practice in adult intensive care units in the United Kingdom. Anaesthesia. 2008 Sep;63(9):959-66. doi: 10.1111/j.1365-2044.2008.05514.x. Epub 2008 Jun 28.
Results publication: PubMed 29118829Borg R, Ugboma D, Walker DM, Partridge R. Evaluating the safety and efficacy of regional citrate compared to systemic heparin as anticoagulation for continuous renal replacement therapy in critically ill patients: A service evaluation following a change in practice. J Intensive Care Soc. 2017 Aug;18(3):184-192. doi: 10.1177/1751143717695835. Epub 2017 Mar 14.
Results publication: PubMed 11193279Cutts MW, Thomas AN, Kishen R. Transfusion requirements during continuous veno-venous haemofiltration: -the importance of filter life. Intensive Care Med. 2000 Nov;26(11):1694-7. doi: 10.1007/s001340000676.
Results publication: PubMed 24993448Morabito S, Pistolesi V, Tritapepe L, Fiaccadori E. Regional citrate anticoagulation for RRTs in critically ill patients with AKI. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2173-88. doi: 10.2215/CJN.01280214. Epub 2014 Jul 3.
Results publication: PubMed 29185591Tuerdi B, Zuo L, Sun H, Wang K, Wang Z, Li G. Safety and efficacy of regional citrate anticoagulation in continuous blood purification treatment of patients with multiple organ dysfunction syndrome. Braz J Med Biol Res. 2017 Nov 17;51(1):e6378. doi: 10.1590/1414-431X20176378.
Results publication: PubMed 27474473Schrezenmeier EV, Barasch J, Budde K, Westhoff T, Schmidt-Ott KM. Biomarkers in acute kidney injury - pathophysiological basis and clinical performance. Acta Physiol (Oxf). 2017 Mar;219(3):554-572. doi: 10.1111/apha.12764. Epub 2016 Aug 25.
Results publication: PubMed 12722043Kwon O, Molitoris BA, Pescovitz M, Kelly KJ. Urinary actin, interleukin-6, and interleukin-8 may predict sustained ARF after ischemic injury in renal allografts. Am J Kidney Dis. 2003 May;41(5):1074-87. doi: 10.1016/s0272-6386(03)00206-3.
Results publication: PubMed 19672112Liangos O, Kolyada A, Tighiouart H, Perianayagam MC, Wald R, Jaber BL. Interleukin-8 and acute kidney injury following cardiopulmonary bypass: a prospective cohort study. Nephron Clin Pract. 2009;113(3):c148-54. doi: 10.1159/000232595. Epub 2009 Aug 12.
Results publication: PubMed 28821332de Fontnouvelle CA, Greenberg JH, Thiessen-Philbrook HR, Zappitelli M, Roth J, Kerr KF, Devarajan P, Shlipak M, Coca S, Parikh CR; TRIBE-AKI Consortium. Interleukin-8 and Tumor Necrosis Factor Predict Acute Kidney Injury After Pediatric Cardiac Surgery. Ann Thorac Surg. 2017 Dec;104(6):2072-2079. doi: 10.1016/j.athoracsur.2017.04.038. Epub 2017 Aug 16.
Derived from this study: PubMed 35412099Trakarnvanich T, Sirivongrangson P, Trongtrakul K, Srisawat N. The effect of citrate in cardiovascular system and clot circuit in critically ill patients requiring continuous renal replacement therapy. J Artif Organs. 2023 Mar;26(1):53-64. doi: 10.1007/s10047-022-01329-0. Epub 2022 Apr 12.
Individual participant dataSharing planned: No

Related trials for Acute Kidney Injury

RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis

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.

Thananda Trakarnvanich, M.D. principal investigator

Renal unit,Faculty of Medicine,Vajira Hospital,Navamindradhiraj University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Regional citrate anticoagulation in people with Acute Kidney Injury and Citrate, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.

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 2 inclusion and 14 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 29 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 Thailand. 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. Some participants in this study may receive a placebo. 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?

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?

Cardiac output (time frame: 72 hour). The study lists 4 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 NCT04865510, which also lists 11 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 29 Apr 2021.