Heart; Surgery, Heart, Functional Disturbance as ResultNCT06085066
The Role of Modified Ultrafiltration Following Open Heart Surgery
A study testing Conventional Ultrafiltration alone on Cardiopulmonary bypass and Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to investigate the effect of combining conventional ultrafiltration and modified ultrafiltration compared to conventional ultrafiltration alone in patients who underwent open heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- Conventional Ultrafiltration alone on Cardiopulmonary bypass and Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2021to 29 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older undergoing elective open heart surgery
- Willing to become a research participant and sign an informed consent statement
Who cannot join
- Patients undergoing redo surgery and emergency surgery
- Patients that have immune disease, chronic lung disease, undergoing hemodialysis
- Patients who are pregnant
- Drop-out Criteria
- Patients who experience repeated back-on bypass
- Patients who experience reopen surgery 24 hours after surgery
- Patients who die within 24 hours after surgery
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta
About this study
Official title: The Role of Modified Ultrafiltration on Vascular Resistance, Cardiac Index Enhancement, and Inflammation Reduction Following Open Heart Surgery; A Randomized Clinical Trial
This study aims to investigate the effect of combining conventional ultrafiltration and modified ultrafiltration compared to conventional ultrafiltration alone in patients who underwent open heart surgery.
Read the detailed description
The target of this study is adult patients diagnosed with coronary heart disease and valve disease who underwent open heart surgery in CICU PJT RSCM and Jakarta Heart Hospital. The research was conducted after obtaining approval from the FKUI-RSCM ethical committee, and the research subjects agreed to participate by signing an informed consent form. The anesthesia team prepared research subjects undergoing surgery with the placement of arterial cannulas, central venous catheters, sheath introducers, pulmonary artery catheters, and anesthesia management. The placement of these instruments aimed at measuring dependent variables studied included Systemic Vascular Resistance (SVR), Pulmonary Vascular Resistance (PVR), Cardiac Index (CI), and IL-6 levels. The CPB machine was used during the heart chamber opening procedure or coronary artery graft placement, and CUF was initiated. After CPB use was concluded, research subjects were allocated to either the control group or the treatment group through randomization. MUF was performed post-CPB in the treatment group, with the pump speed not exceeding 10% of full flow for 10 minutes. IL-6 levels were measured twice, namely before induction of anesthesia and 24 hours after CPB. SVR, PVR, and CI measurements were carried out before CPB, post-CPB, 10 minutes post-CPB, and 24 hours post-CPB.
- Being tested
- Conventional Ultrafiltration alone on Cardiopulmonary bypass, Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass
- Keywords
- Cardiopulmonary bypass, Conventional ultrafiltration, Modified ultrafiltration, Systemic vascular resistance, Pulmonary vascular resistance, Cardiac output index, Interleukin-6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Ultrafiltration alone on Cardiopulmonary bypassProcedure or surgery
Conventional Ultrafiltration was used on Cardiopulmonary bypass for patients who underwent open heart surgery
Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypassProcedure or surgery
Modified Ultrafiltration was used following the Conventional Ultrafiltration on Cardiopulmonary bypass for patients who underwent open heart surgery
| Study group | Role | What they receive |
|---|---|---|
| Conventional Ultrafiltration alone on Cardiopulmonary bypass | Active comparator | Conventional ultrafiltration was used on a cardiopulmonary bypass procedure for patients who underwent open heart surgery Receives: Procedure: Conventional Ultrafiltration alone on Cardiopulmonary bypass |
| Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass | Active comparator | Modified ultrafiltration was used following the conventional ultrafiltration on cardiopulmonary bypass procedure for patients who underwent open heart surgery Receives: Procedure: Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6
Comparison of IL-6 levels between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. IL-6 levels were assessed using blood samples drawn through a Central Venous Catheter installed before the procedure. Elevated IL-6 levels are indicative of heightened inflammation in the patient, correlating with a more adverse outcome.
Measured: 24 hours
Systemic Vascular Resistance (SVR)
Comparison of SVR between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass.
SVR is the aortic resistance value that the left heart must surpass to pump blood out effectively. SVR measurements are acquired by placing a Pulmonary Artery Catheter in the jugular vein, which is subsequently connected to a Philips monitor. This allows for automatic reading of SVR in dyne.sec/cm5 units through the monitor.
Measured: 24 hours
Pulmonary Vascular Resistance (PVR)
Comparison of PVR between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. PVR is the pulmonary artery resistance value that the right heart must surmount to efficiently pump blood out. PVR measurements are derived from the insertion of a Pulmonary Artery Catheter via the jugular vein, which is subsequently linked to a Philips monitor, facilitating automated readings in units of dyne.sec/cm5 through the monitor.
Measured: 24 hours
Cardiac Index
Comparison of Cardiac Index between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. The cardiac index (CI) represents the volume of blood continuously ejected from the left heart in one minute, relative to the body surface area. CI measurements are acquired through the insertion of a Pulmonary Artery Catheter via the jugular vein, which is subsequently linked to a Philips monitor. This allows for automatic readings in units of L/minute/m2. A higher CI value corresponds to a more favorable patient outcome.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Dec 2021
- Primary completion31 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ratna Farida Soenarto, Universitas Indonesia
- Investigators
- Ratna F Soenarto, Consultant, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085066
- Sponsor's protocol ID
- IndonesiaUAnes1000
- Status last verified
- Mar 2024
- First submitted
- 2 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahmoud AB, Burhani MS, Hannef AA, Jamjoom AA, Al-Githmi IS, Baslaim GM. Effect of modified ultrafiltration on pulmonary function after cardiopulmonary bypass. Chest. 2005 Nov;128(5):3447-53. doi: 10.1378/chest.128.5.3447.
PubMed 16304298Luciani GB, Menon T, Vecchi B, Auriemma S, Mazzucco A. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation. 2001 Sep 18;104(12 Suppl 1):I253-9. doi: 10.1161/hc37t1.094931.
PubMed 11568065Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.
PubMed 27671216Chandler HK, Kirsch R. Management of the Low Cardiac Output Syndrome Following Surgery for Congenital Heart Disease. Curr Cardiol Rev. 2016;12(2):107-11. doi: 10.2174/1573403x12666151119164647.
PubMed 26585039Suleiman MS, Zacharowski K, Angelini GD. Inflammatory response and cardioprotection during open-heart surgery: the importance of anaesthetics. Br J Pharmacol. 2008 Jan;153(1):21-33. doi: 10.1038/sj.bjp.0707526. Epub 2007 Oct 22.
PubMed 17952108Young RW. Prevention of lung injury in cardiac surgery: a review. J Extra Corpor Technol. 2014 Jun;46(2):130-41.
PubMed 25208430Paparella D, Yau TM, Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 Feb;21(2):232-44. doi: 10.1016/s1010-7940(01)01099-5.
PubMed 11825729Bronicki RA, Hall M. Cardiopulmonary Bypass-Induced Inflammatory Response: Pathophysiology and Treatment. Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S272-8. doi: 10.1097/PCC.0000000000000759.
PubMed 27490610Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24.
PubMed 26116810Atkins BZ, Danielson DS, Fitzpatrick CM, Dixon P, Petersen RP, Carpenter AJ. Modified ultrafiltration attenuates pulmonary-derived inflammatory mediators in response to cardiopulmonary bypass. Interact Cardiovasc Thorac Surg. 2010 Nov;11(5):599-603. doi: 10.1510/icvts.2010.234344. Epub 2010 Aug 3.
PubMed 20682630Sheikhi MA, Ebadi A, Shahriary A, Davoodzadeh H, Rahmani H. Cardiac Surgery Anesthesia And Systemic Inflammatory Response. Int J Bioassays. 2015;4(2):3648-3655. doi: 10.21746/ijbio.2015.02.005.
PubMed 27857938Muller-Werdan U, Prondzinsky R, Werdan K. Effect of inflammatory mediators on cardiovascular function. Curr Opin Crit Care. 2016 Oct;22(5):453-63. doi: 10.1097/MCC.0000000000000345.
PubMed 27583586Chew MS, Brix-Christensen V, Ravn HB, Brandslund I, Ditlevsen E, Pedersen J, Hjortholm K, Hansen OK, Tonnesen E, Hjortdal VE. Effect of modified ultrafiltration on the inflammatory response in paediatric open-heart surgery: a prospective, randomized study. Perfusion. 2002 Sep;17(5):327-33. doi: 10.1191/0267659102pf595oa.
PubMed 12243435Ziyaeifard M, Alizadehasl A, Aghdaii N, Rahimzadeh P, Masoumi G, Golzari SE, Fatahi M, Gorjipur F. The effect of combined conventional and modified ultrafiltration on mechanical ventilation and hemodynamic changes in congenital heart surgery. J Res Med Sci. 2016 Nov 7;21:113. doi: 10.4103/1735-1995.193504. eCollection 2016.
PubMed 28255321Perez-Vela JL, Ruiz-Alonso E, Guillen-Ramirez F, Garcia-Maellas MT, Renes-Carreno E, Cerro-Garcia M, Cortina-Romero J, Hernandez-Rodriguez I. ICU outcomes in adult cardiac surgery patients in relation to ultrafiltration type. Perfusion. 2008 Mar;23(2):79-87. doi: 10.1177/0267659108095167.
PubMed 18840575
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Modified Ultrafiltration on Vascular Resistance, Cardiac Index Enhancement, and Inflammation Reduction Following Open Heart Surgery; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06085066
- Acronym / sponsor ID
- IndonesiaUAnes1000
- Keywords
- Cardiopulmonary bypass, Conventional ultrafiltration, Modified ultrafiltration, Systemic vascular resistance, Pulmonary vascular resistance, Cardiac output index, Interleukin-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 16 Oct 2023 (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.
This study aims to investigate the effect of combining conventional ultrafiltration and modified ultrafiltration compared to conventional ultrafiltration alone in patients who underwent open heart surgery.
Detailed description
The target of this study is adult patients diagnosed with coronary heart disease and valve disease who underwent open heart surgery in CICU PJT RSCM and Jakarta Heart Hospital. The research was conducted after obtaining approval from the FKUI-RSCM ethical committee, and the research subjects agreed to participate by signing an informed consent form. The anesthesia team prepared research subjects undergoing surgery with the placement of arterial cannulas, central venous catheters, sheath introducers, pulmonary artery catheters, and anesthesia management. The placement of these instruments aimed at measuring dependent variables studied included Systemic Vascular Resistance (SVR), Pulmonary Vascular Resistance (PVR), Cardiac Index (CI), and IL-6 levels. The CPB machine was used during the heart chamber opening procedure or coronary artery graft placement, and CUF was initiated. After CPB use was concluded, research subjects were allocated to either the control group or the treatment group through randomization. MUF was performed post-CPB in the treatment group, with the pump speed not exceeding 10% of full flow for 10 minutes. IL-6 levels were measured twice, namely before induction of anesthesia and 24 hours after CPB. SVR, PVR, and CI measurements were carried out before CPB, post-CPB, 10 minutes post-CPB, and 24 hours post-CPB.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Ultrafiltration alone on Cardiopulmonary bypass | Active comparator | Procedure: Conventional Ultrafiltration alone on Cardiopulmonary bypassConventional ultrafiltration was used on a cardiopulmonary bypass procedure for patients who underwent open heart surgery |
| Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass | Active comparator | Procedure: Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypassModified ultrafiltration was used following the conventional ultrafiltration on cardiopulmonary bypass procedure for patients who underwent open heart surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged 18 years or older undergoing elective open heart surgery
- Willing to become a research participant and sign an informed consent statement
Key exclusion criteria (7 listed)
- Patients undergoing redo surgery and emergency surgery
- Patients that have immune disease, chronic lung disease, undergoing hemodialysis
- Patients who are pregnant
- Drop-out Criteria
- Patients who experience repeated back-on bypass
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 |
|---|---|---|
| Conventional Ultrafiltration alone on Cardiopulmonary bypassConventional Ultrafiltration was used on Cardiopulmonary bypass for patients who underwent open heart surgery | Procedure or surgery | Conventional Ultrafiltration alone on Cardiopulmonary bypass |
| Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypassModified Ultrafiltration was used following the Conventional Ultrafiltration on Cardiopulmonary bypass for patients who underwent open heart surgery | Procedure or surgery | Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass |
Primary outcome
Interleukin-6
Time frame: 24 hours
Comparison of IL-6 levels between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. IL-6 levels were assessed using blood samples drawn through a Central Venous Catheter installed before the procedure. Elevated IL-6 levels are indicative of heightened inflammation in the patient, correlating with a more adverse outcome.
Systemic Vascular Resistance (SVR)
Time frame: 24 hours
Comparison of SVR between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. SVR is the aortic resistance value that the left heart must surpass to pump blood out effectively. SVR measurements are acquired by placing a Pulmonary Artery Catheter in the jugular vein, which is subsequently connected to a Philips monitor. This allows for automatic reading of SVR in dyne.sec/cm5 units through the monitor.
Pulmonary Vascular Resistance (PVR)
Time frame: 24 hours
Comparison of PVR between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. PVR is the pulmonary artery resistance value that the right heart must surmount to efficiently pump blood out. PVR measurements are derived from the insertion of a Pulmonary Artery Catheter via the jugular vein, which is subsequently linked to a Philips monitor, facilitating automated readings in units of dyne.sec/cm5 through the monitor.
Cardiac Index
Time frame: 24 hours
Comparison of Cardiac Index between combination conventional ultrafiltration and modified ultrafiltration with conventional ultrafiltration only on cardiopulmonary bypass. The cardiac index (CI) represents the volume of blood continuously ejected from the left heart in one minute, relative to the body surface area. CI measurements are acquired through the insertion of a Pulmonary Artery Catheter via the jugular vein, which is subsequently linked to a Philips monitor. This allows for automatic readings in units of L/minute/m2. A higher CI value corresponds to a more favorable patient outcome.
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 15 Mar 2024.
- Background: PubMed 16304298Mahmoud AB, Burhani MS, Hannef AA, Jamjoom AA, Al-Githmi IS, Baslaim GM. Effect of modified ultrafiltration on pulmonary function after cardiopulmonary bypass. Chest. 2005 Nov;128(5):3447-53. doi: 10.1378/chest.128.5.3447.
- Background: PubMed 11568065Luciani GB, Menon T, Vecchi B, Auriemma S, Mazzucco A. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation. 2001 Sep 18;104(12 Suppl 1):I253-9. doi: 10.1161/hc37t1.094931.
- Background: PubMed 27671216Lomivorotov VV, Efremov SM, Kirov MY, Fominskiy EV, Karaskov AM. Low-Cardiac-Output Syndrome After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):291-308. doi: 10.1053/j.jvca.2016.05.029. Epub 2016 Jul 29. No abstract available.
- Background: PubMed 26585039Chandler HK, Kirsch R. Management of the Low Cardiac Output Syndrome Following Surgery for Congenital Heart Disease. Curr Cardiol Rev. 2016;12(2):107-11. doi: 10.2174/1573403x12666151119164647.
- Background: PubMed 17952108Suleiman MS, Zacharowski K, Angelini GD. Inflammatory response and cardioprotection during open-heart surgery: the importance of anaesthetics. Br J Pharmacol. 2008 Jan;153(1):21-33. doi: 10.1038/sj.bjp.0707526. Epub 2007 Oct 22.
- Background: PubMed 25208430Young RW. Prevention of lung injury in cardiac surgery: a review. J Extra Corpor Technol. 2014 Jun;46(2):130-41.
- Background: PubMed 11825729Paparella D, Yau TM, Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 Feb;21(2):232-44. doi: 10.1016/s1010-7940(01)01099-5.
- Background: PubMed 27490610Bronicki RA, Hall M. Cardiopulmonary Bypass-Induced Inflammatory Response: Pathophysiology and Treatment. Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S272-8. doi: 10.1097/PCC.0000000000000759.
- Background: PubMed 26116810Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24.
- Background: PubMed 20682630Atkins BZ, Danielson DS, Fitzpatrick CM, Dixon P, Petersen RP, Carpenter AJ. Modified ultrafiltration attenuates pulmonary-derived inflammatory mediators in response to cardiopulmonary bypass. Interact Cardiovasc Thorac Surg. 2010 Nov;11(5):599-603. doi: 10.1510/icvts.2010.234344. Epub 2010 Aug 3.
- Background: PubMed 27857938Sheikhi MA, Ebadi A, Shahriary A, Davoodzadeh H, Rahmani H. Cardiac Surgery Anesthesia And Systemic Inflammatory Response. Int J Bioassays. 2015;4(2):3648-3655. doi: 10.21746/ijbio.2015.02.005.
- Background: PubMed 27583586Muller-Werdan U, Prondzinsky R, Werdan K. Effect of inflammatory mediators on cardiovascular function. Curr Opin Crit Care. 2016 Oct;22(5):453-63. doi: 10.1097/MCC.0000000000000345.
- 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.
Ratna F Soenarto, Consultant principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Ultrafiltration alone on Cardiopulmonary bypass and Conventional Ultrafiltration followed by Modified Ultrafitration on Cardiopulmonary bypass in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by Universitas Indonesia at 1 site in Indonesia.
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 7 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 15 Mar 2024. 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 Indonesia. 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?
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?
Interleukin-6 (time frame: 24 hours). 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 NCT06085066, which also lists 17 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 15 Mar 2024.