SepsisPhase 2NCT04313790
Assessment of the Anti-inflammatory Effect of Heparin Infusion Versus Subcutaneous Injection in Septic Patients
A Phase 2 study testing Heparin Infusion and subcutaneous heparin in people with Sepsis and Critical Illness, run by Damanhour University at 1 site in Egypt.
Trial summary
Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep venous thrombosis (DVT), is a common and severe complication of critical illness. Critically ill patients are at high risk of VTE because they combine both general risk factors together with specific ICU risk factors of VTE. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sepsis, Critical Illness
- What is being tested?
- Heparin Infusion and subcutaneous heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2020to 11 Oct 2022
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults Patients aged 18 years old or greatecritically ill patients aged 18-65 years diagnosed with sepsis/septic shock or developed sepsis/septic shock during their ICU length of stay were enrolled.
Who cannot join
- -Thrombocytopenia, Intracerebral hemorrhage at the time of sepsis Bleeding tendency (INR ≥ 1.5 or PLT < 50 x 109/L,) Medical condition requiring therapeutic anticoagulation Age < 18 years Previous history of Heparin Induced Thrombocytopenia (HIT).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Anti-inflammatory Effect of Unfractionated Heparin Administered Either by Intravenous Infusion Versus Subcutaneous Injection in Critically Ill Septic Patients. A Randomized Controlled Trial
Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep venous thrombosis (DVT), is a common and severe complication of critical illness. Critically ill patients are at high risk of VTE because they combine both general risk factors together with specific ICU risk factors of VTE. Vasopressor administration was found to be an independent risk factor for DVT. certainly explained by reduced absorption of subcutaneous heparin linked to the vasoconstriction of peripheral blood vessels. For critically ill patients, due to the altered pharmacokinetics behavior of unfractionated heparin, continuous intravenous infusion of the low doses of unfractionated heparin has been proposed. Standard prophylaxis with subcutaneous (SC) heparin is less efficient in patients requiring vasopressors. Sepsis is a systemic inflammatory response due to an infection. Both inflammatory mediators and coagulation are involved in sepsis. the release of inflammatory mediators such as interleukins and tumor necrosis factor causes damage to the endothelium and activation of coagulation which promotes the inflammatory process. Unfractionated heparin is the most negatively charged biological molecule known, heparin has a strong ability to interfere with the functioning of positively charged molecules. Due to the difference in charges, heparin has been documented to interact with over 100 proteins.57 Interleukins, cytokines, and receptors located on endothelial cells, which are involved in the acute phase response, are positively charged and thus are a reasonable target for the modulating effects of heparin. Heparin has strong anti-inflammatory effects with many possible mechanisms, including binding to cell-surface glycosaminoglycans, preventing leukocyte migration, direct binding to chemokines and cytokines, and inhibition of intracellular NF-kB.
Read the detailed description
- Ethical committee approval will be obtained from the Ethics Committee of the Faculty of Pharmacy, Damanhour University.
- All participants or their next kin should agree to participate in this clinical study and will provide informed consent.
- 40 participants who are critically ill with sepsis.
- The 40 participants will be randomly assigned into 2 groups:
- Standard care group: will be treated with subcutaneous heparin 5000 units three times daily for DVT prophylaxis.
- Experimental group: will be treated with heparin infusion 5000 unit\hour for DVT prophylaxis
- All patients will be subjected directly at the time of enrollment to the following:
- Full patient history and clinical examination.
- complete blood picture, liver function tests, and renal function tests.
- The initial cause of ICU admission and define the origin of the present infection.
- Complete cultures obtained urine, blood, and sputum.
- Coagulation profile (prothrombin time, prothrombin activity, international normalization ratio (INR), clotting time, and activated partial thromboplastin time).
- Arterial blood gases analysis (including hypoxic index).
- The severity of disease assessment using Acute Physiology and Chronic Health Evaluation version II (APACHE II) score.
- Organ failure assessment using Organ Failure Assessment (SOFA) score and quick (SOFA) score.
- Kidney assessment using Kidney Disease Improving Global Outcomes (KDIGO) criteria.
- Liver disease assessment using Child-Pugh Score.
- Chest radiography, electrocardiography, and transthoracic echocardiography.
- Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate temperature, blood sugar level, and urine output).
- All patients will be monitored for the incidence of DVT, minor and major bleeding during their intensive care unit stay (ICU).
- Coagulation profile, serum lactate, serum electrolytes, hypoxic index,14-day mortality, and the following pro-inflammatory biomarkers will be measured at the start and at days 1,2, and 7 of the study.
- CRP ii. Heparin-binding protein (HBP) iii. Plasminogen activator inhibitor (PAI).
- Patient demographic data will be recorded with respect to sex. age, weight, disease, and medication history.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion, and recommendations will be given.
- A p-value of less than 0.05 will be considered statistically significant.
- The study data were evaluated using IBM SPSS software (statistical product and service solution version 26.0)
- Conditions
- Sepsis, Critical Illness
- Being tested
- Heparin Infusion, subcutaneous heparin
- Keywords
- heparin infusion, DVT prophylaxis, Anti inflammatory
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin InfusionDrug
Also called new regimen
500 unit heparin infusion \ hour for DVT prophylaxis experimental group (n=20)
subcutaneous heparinOther
Also called conventional regimen
5000 unit subcutaneous heparin /8 hours control group n=(20)
| Study group | Role | What they receive |
|---|---|---|
| Heparin Infusion | Experimental | heparin infusion 500unit \hour Receives: Drug: Heparin Infusion |
| Subcutaneus Heparin | Other | subcutaneous heparin 5000unit \ 8 hours Receives: Other: subcutaneous heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes of HBP
Measuring the differences of HBP dynamic changes between the two study groups
Measured: day one, two, and seven
Dynamic changes of PAL-1
Measuring the differences of PAL-1 dynamic changes between the two study groups
Measured: day one, two, and seven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start29 Aug 2020
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Salahuddin, PHD, Study director, Damanhour UniversityAymen A Eltayar, MD, Study director, Damanhour Teatching HospitalNoha A El Bassiouny, PHD, Study chair, Damanhour UniversityAmira B Kassem, PHD, Study chair, Damanhour UniversityNouran A Elsheikh, Pharm-D, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313790
- Sponsor's protocol ID
- IVSCHEP
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook D, Crowther M, Meade M, Rabbat C, Griffith L, Schiff D, Geerts W, Guyatt G. Deep venous thrombosis in medical-surgical critically ill patients: prevalence, incidence, and risk factors. Crit Care Med. 2005 Jul;33(7):1565-71. doi: 10.1097/01.ccm.0000171207.95319.b2.
PubMed 16003063Dorffler-Melly J, de Jonge E, Pont AC, Meijers J, Vroom MB, Buller HR, Levi M. Bioavailability of subcutaneous low-molecular-weight heparin to patients on vasopressors. Lancet. 2002 Mar 9;359(9309):849-50. doi: 10.1016/s0140-6736(02)07920-5.
PubMed 11897286Selby R, Geerts W. Prevention of venous thromboembolism: consensus, controversies, and challenges. Hematology Am Soc Hematol Educ Program. 2009:286-92. doi: 10.1182/asheducation-2009.1.286.
PubMed 20008212Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):188S-203S. doi: 10.1378/chest.126.3_suppl.188S.
PubMed 15383472Jaimes F, De La Rosa G, Morales C, Fortich F, Arango C, Aguirre D, Munoz A. Unfractioned heparin for treatment of sepsis: A randomized clinical trial (The HETRASE Study). Crit Care Med. 2009 Apr;37(4):1185-96. doi: 10.1097/CCM.0b013e31819c06bc.
PubMed 19242322Wang C, Chi C, Guo L, Wang X, Guo L, Sun J, Sun B, Liu S, Chang X, Li E. Heparin therapy reduces 28-day mortality in adult severe sepsis patients: a systematic review and meta-analysis. Crit Care. 2014 Oct 16;18(5):563. doi: 10.1186/s13054-014-0563-4.
PubMed 25318353Lorente L, Martin MM, Borreguero-Leon JM, Sole-Violan J, Ferreres J, Labarta L, Diaz C, Jimenez A, Paramo JA. Sustained high plasma plasminogen activator inhibitor-1 levels are associated with severity and mortality in septic patients. Thromb Res. 2014 Jul;134(1):182-6. doi: 10.1016/j.thromres.2014.04.013. Epub 2014 Apr 29.
PubMed 24814968Elsayed E, Becker RC. The impact of heparin compounds on cellular inflammatory responses: a construct for future investigation and pharmaceutical development. J Thromb Thrombolysis. 2003 Feb;15(1):11-8. doi: 10.1023/a:1026184100030.
PubMed 14574071Li L, Pian Y, Chen S, Hao H, Zheng Y, Zhu L, Xu B, Liu K, Li M, Jiang H, Jiang Y. Phenol-soluble modulin alpha4 mediates Staphylococcus aureus-associated vascular leakage by stimulating heparin-binding protein release from neutrophils. Sci Rep. 2016 Jul 7;6:29373. doi: 10.1038/srep29373.
PubMed 27383625Chen S, Xie W, Wu K, Li P, Ren Z, Li L, Yuan Y, Zhang C, Zheng Y, Lv Q, Jiang H, Jiang Y. Suilysin Stimulates the Release of Heparin Binding Protein from Neutrophils and Increases Vascular Permeability in Mice. Front Microbiol. 2016 Aug 26;7:1338. doi: 10.3389/fmicb.2016.01338. eCollection 2016.
PubMed 27617009Tyden J, Herwald H, Hultin M, Wallden J, Johansson J. Heparin-binding protein as a biomarker of acute kidney injury in critical illness. Acta Anaesthesiol Scand. 2017 Aug;61(7):797-803. doi: 10.1111/aas.12913. Epub 2017 Jun 5.
PubMed 28585315Fisher J, Russell JA, Bentzer P, Parsons D, Secchia S, Morgelin M, Walley KR, Boyd JH, Linder A. Heparin-Binding Protein (HBP): A Causative Marker and Potential Target for Heparin Treatment of Human Sepsis-Induced Acute Kidney Injury. Shock. 2017 Sep;48(3):313-320. doi: 10.1097/SHK.0000000000000862.
PubMed 28319494Lin Q, Shen J, Shen L, Zhang Z, Fu F. Increased plasma levels of heparin-binding protein in patients with acute respiratory distress syndrome. Crit Care. 2013 Jul 24;17(4):R155. doi: 10.1186/cc12834.
PubMed 23883488
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Anti-inflammatory Effect of Unfractionated Heparin Administered Either by Intravenous Infusion Versus Subcutaneous Injection in Critically Ill Septic Patients. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04313790
- Acronym / sponsor ID
- IVSCHEP
- Conditions
- Sepsis, Critical Illness
- Keywords
- heparin infusion, DVT prophylaxis, Anti inflammatory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 29 Aug 2020 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 18 Mar 2020 (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.
Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep venous thrombosis (DVT), is a common and severe complication of critical illness. Critically ill patients are at high risk of VTE because they combine both general risk factors together with specific ICU risk factors of VTE. Vasopressor administration was found to be an independent risk factor for DVT. certainly explained by reduced absorption of subcutaneous heparin linked to the vasoconstriction of peripheral blood vessels. For critically ill patients, due to the altered pharmacokinetics behavior of unfractionated heparin, continuous intravenous infusion of the low doses of unfractionated heparin has been proposed. Standard prophylaxis with subcutaneous (SC) heparin is less efficient in patients requiring vasopressors. Sepsis is a systemic inflammatory response due to an infection. Both inflammatory mediators and coagulation are involved in sepsis. the release of inflammatory mediators such as interleukins and tumor necrosis factor causes damage to the endothelium and activation of coagulation which promotes the inflammatory process. Unfractionated heparin is the most negatively charged biological molecule known, heparin has a strong ability to interfere with the functioning of positively charged molecules. Due to the difference in charges, heparin has been documented to interact with over 100 proteins.57 Interleukins, cytokines, and receptors located on endothelial cells, which are involved in the acute phase response, are positively charged and thus are a reasonable target for the modulating effects of heparin. Heparin has strong anti-inflammatory effects with many possible mechanisms, including binding to cell-surface glycosaminoglycans, preventing leukocyte migration, direct binding to chemokines and cytokines, and inhibition of intracellular NF-kB.
Detailed description
- Ethical committee approval will be obtained from the Ethics Committee of the Faculty of Pharmacy, Damanhour University.
- All participants or their next kin should agree to participate in this clinical study and will provide informed consent.
- 40 participants who are critically ill with sepsis.
- The 40 participants will be randomly assigned into 2 groups:
- Standard care group: will be treated with subcutaneous heparin 5000 units three times daily for DVT prophylaxis.
- Experimental group: will be treated with heparin infusion 5000 unit\hour for DVT prophylaxis
- All patients will be subjected directly at the time of enrollment to the following:
- Full patient history and clinical examination.
- complete blood picture, liver function tests, and renal function tests.
- The initial cause of ICU admission and define the origin of the present infection.
- Complete cultures obtained urine, blood, and sputum.
- Coagulation profile (prothrombin time, prothrombin activity, international normalization ratio (INR), clotting time, and activated partial thromboplastin time).
- Arterial blood gases analysis (including hypoxic index).
- The severity of disease assessment using Acute Physiology and Chronic Health Evaluation version II (APACHE II) score.
- Organ failure assessment using Organ Failure Assessment (SOFA) score and quick (SOFA) score.
- Kidney assessment using Kidney Disease Improving Global Outcomes (KDIGO) criteria.
- Liver disease assessment using Child-Pugh Score.
- Chest radiography, electrocardiography, and transthoracic echocardiography.
- Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate temperature, blood sugar level, and urine output).
- All patients will be monitored for the incidence of DVT, minor and major bleeding during their intensive care unit stay (ICU).
- Coagulation profile, serum lactate, serum electrolytes, hypoxic index,14-day mortality, and the following pro-inflammatory biomarkers will be measured at the start and at days 1,2, and 7 of the study.
- CRP ii. Heparin-binding protein (HBP) iii. Plasminogen activator inhibitor (PAI).
- Patient demographic data will be recorded with respect to sex. age, weight, disease, and medication history.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion, and recommendations will be given.
- A p-value of less than 0.05 will be considered statistically significant.
- The study data were evaluated using IBM SPSS software (statistical product and service solution version 26.0)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Heparin Infusion | Experimental | Drug: Heparin Infusionheparin infusion 500unit \hour |
| Subcutaneus Heparin | Other | Other: subcutaneous heparinsubcutaneous heparin 5000unit \ 8 hours |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults Patients aged 18 years old or greatecritically ill patients aged 18-65 years diagnosed with sepsis/septic shock or developed sepsis/septic shock during their ICU length of stay were enrolled.
Key exclusion criteria (1 listed)
- -Thrombocytopenia, Intracerebral hemorrhage at the time of sepsis Bleeding tendency (INR ≥ 1.5 or PLT < 50 x 109/L,) Medical condition requiring therapeutic anticoagulation Age < 18 years Previous history of Heparin Induced Thrombocytopenia (HIT).
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 |
|---|---|---|
| Heparin InfusionAlso: new regimen500 unit heparin infusion \ hour for DVT prophylaxis experimental group (n=20) | Drug | Heparin Infusion |
| subcutaneous heparinAlso: conventional regimen5000 unit subcutaneous heparin /8 hours control group n=(20) | Other | Subcutaneus Heparin |
Primary outcome
Dynamic changes of HBP
Time frame: day one, two, and seven
Measuring the differences of HBP dynamic changes between the two study groups
Dynamic changes of PAL-1
Time frame: day one, two, and seven
Measuring the differences of PAL-1 dynamic changes between the two study groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 16003063Cook D, Crowther M, Meade M, Rabbat C, Griffith L, Schiff D, Geerts W, Guyatt G. Deep venous thrombosis in medical-surgical critically ill patients: prevalence, incidence, and risk factors. Crit Care Med. 2005 Jul;33(7):1565-71. doi: 10.1097/01.ccm.0000171207.95319.b2.
- Background: PubMed 11897286Dorffler-Melly J, de Jonge E, Pont AC, Meijers J, Vroom MB, Buller HR, Levi M. Bioavailability of subcutaneous low-molecular-weight heparin to patients on vasopressors. Lancet. 2002 Mar 9;359(9309):849-50. doi: 10.1016/s0140-6736(02)07920-5.
- Background: PubMed 20008212Selby R, Geerts W. Prevention of venous thromboembolism: consensus, controversies, and challenges. Hematology Am Soc Hematol Educ Program. 2009:286-92. doi: 10.1182/asheducation-2009.1.286.
- Background: PubMed 15383472Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):188S-203S. doi: 10.1378/chest.126.3_suppl.188S.
- Background: PubMed 19242322Jaimes F, De La Rosa G, Morales C, Fortich F, Arango C, Aguirre D, Munoz A. Unfractioned heparin for treatment of sepsis: A randomized clinical trial (The HETRASE Study). Crit Care Med. 2009 Apr;37(4):1185-96. doi: 10.1097/CCM.0b013e31819c06bc.
- Background: PubMed 25318353Wang C, Chi C, Guo L, Wang X, Guo L, Sun J, Sun B, Liu S, Chang X, Li E. Heparin therapy reduces 28-day mortality in adult severe sepsis patients: a systematic review and meta-analysis. Crit Care. 2014 Oct 16;18(5):563. doi: 10.1186/s13054-014-0563-4.
- Background: PubMed 24814968Lorente L, Martin MM, Borreguero-Leon JM, Sole-Violan J, Ferreres J, Labarta L, Diaz C, Jimenez A, Paramo JA. Sustained high plasma plasminogen activator inhibitor-1 levels are associated with severity and mortality in septic patients. Thromb Res. 2014 Jul;134(1):182-6. doi: 10.1016/j.thromres.2014.04.013. Epub 2014 Apr 29.
- Background: PubMed 14574071Elsayed E, Becker RC. The impact of heparin compounds on cellular inflammatory responses: a construct for future investigation and pharmaceutical development. J Thromb Thrombolysis. 2003 Feb;15(1):11-8. doi: 10.1023/a:1026184100030.
- Background: PubMed 27383625Li L, Pian Y, Chen S, Hao H, Zheng Y, Zhu L, Xu B, Liu K, Li M, Jiang H, Jiang Y. Phenol-soluble modulin alpha4 mediates Staphylococcus aureus-associated vascular leakage by stimulating heparin-binding protein release from neutrophils. Sci Rep. 2016 Jul 7;6:29373. doi: 10.1038/srep29373.
- Background: PubMed 27617009Chen S, Xie W, Wu K, Li P, Ren Z, Li L, Yuan Y, Zhang C, Zheng Y, Lv Q, Jiang H, Jiang Y. Suilysin Stimulates the Release of Heparin Binding Protein from Neutrophils and Increases Vascular Permeability in Mice. Front Microbiol. 2016 Aug 26;7:1338. doi: 10.3389/fmicb.2016.01338. eCollection 2016.
- Background: PubMed 28585315Tyden J, Herwald H, Hultin M, Wallden J, Johansson J. Heparin-binding protein as a biomarker of acute kidney injury in critical illness. Acta Anaesthesiol Scand. 2017 Aug;61(7):797-803. doi: 10.1111/aas.12913. Epub 2017 Jun 5.
- Background: PubMed 28319494Fisher J, Russell JA, Bentzer P, Parsons D, Secchia S, Morgelin M, Walley KR, Boyd JH, Linder A. Heparin-Binding Protein (HBP): A Causative Marker and Potential Target for Heparin Treatment of Human Sepsis-Induced Acute Kidney Injury. Shock. 2017 Sep;48(3):313-320. doi: 10.1097/SHK.0000000000000862.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Ahmed M Salahuddin, PHD study director
Damanhour University
Aymen A Eltayar, MD study director
Damanhour Teatching Hospital
Noha A El Bassiouny, PHD study chair
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Heparin Infusion and subcutaneous heparin in people with Sepsis and Critical Illness, run by Damanhour University at 1 site in Egypt.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. 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 Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic changes of HBP (time frame: day one, two, and seven). 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 NCT04313790, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.