Heart Rhythm DisorderNCT06742164
Role of Ivabradine for Heart Rate Control in Management of Patients With Sepsis and Septic Shock
A study testing Ivabradine 5mg Tab in people with Heart Rhythm Disorder, run by Ain Shams University.
Trial summary
Tachycardia is associated with excess mortality during septic shock. This may be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function and less effect of administered exogenous catecholamines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Rhythm Disorder
- What is being tested?
- Ivabradine 5mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Jun 2025
- 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
- Patients with proven or suspected site of infection.
- Patients sepsis (acute organ dysfunction secondary to documented or suspected infection)
- Patients with septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure) for at least 6 hours and less than 24 hours.
- Patients with sinus rhythm with heart rate ≥ 95 bpm at time of randomization. Informed consent obtained in accordance with local regulations.
Who cannot join
- Cardiac arrhythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), atrial fibrillation and heart block.
- Cardiogenic shock or acute heart failure, without proven or suspected infection.
- Acute coronary syndrome.
- Refractory shock with systolic arterial pressure <90 mm Hg despite the use of high doses of vasopressors.
- Co-treatment with drugs inducing bradycardia.
- Patients with pacemakers.
Show all 11Show fewer
- Known pregnancy, breast-feeding, women with of childbearing potential will be tested for pregnancy and excluded if pregnant.
- Known allergy to Ivabradine
- Severe renal failure (creatinine clearance <15 ml/min) or hepatic failure (prothrombin time <20%)
- Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (<7 g/dl)
- Enteral feeding impossible.
About this study
Tachycardia is associated with excess mortality during septic shock. This may be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function and less effect of administered exogenous catecholamines.
In this study, we evaluate the effect of enteral Ivabradine on outcome of septic patients regarding need for vasopressor therapy, mechanical ventilation, renal replacement therapy, length of ICU stay and in-hospital mortality.
Read the detailed description
All patients will be subjected to:
- Thorough history taking:
- Demographic data: age, sex and residence.
- Clinical presentation (fever, hypotension , tachycardia , tachypnea and anuria) .
- Family history of immunodeficiency disease
- History of recurrent
- Clinical examination:
- Vital signs: heart rate (HR) , blood pressure (BP), and temperature.
- Abdominal examination .
- Detect septic focus .
- Urine out put .
- Follow up until discharge from ICU.
- Laboratory investigations:
All patient will be screened with :
- Kidney function test .
- Liver function test.
- Total leukocyticcount was assessed immediately after admission to ICU and then every other day
- C-reactive protien was assessed immediately after admission to ICU and then every other day
- Broad-spectrum antibiotic and then according to cultures and sensitivity.
- Radiological investigation .
- Abdominal ultrasound.
- ECG.
- Echocardiography.
Study tools and procedures:
Epidemiological, demographic, clinical, laboratory, treatment, and outcome data will be obtained from medical records using a standardized data collection form.
Data will be obtained by Randomized controlled clinical trial (RCT) of medical records after, the study methodology reviewed and approved by the Research Review Board of Alhelal hospital (Intensive care unit), Faculty of medicine, Ain Shams University hospitals (Intensive care unit) .
The point of enrolment after initial haemodynamic stabilisation was taken as time 0. The following data sets were recorded at the specified time intervals.
An arterial line and central venous catheter were inserted in all patients for invasive blood pressure and central venous pressure monitoring. The point of enrolment after initial haemodynamic stabilisation was taken as time 0.
If the heart rate was less than 70 beats /min. the dose was omitted. The initial mangement of patients with sepsis and septic shock is summarised on three pillars of therapy.
Stabilization of haemodynamics with target mean arterial blood pressure at 65 mmHg for most patients, begain to rapidly administer 30ml/kg balanced crystalloid within 3 hours for hypotension or lactate ≥ 4mmol/L , Apply vasopressor if hypotensive during or after fluid resuscitation (The vasopressor of choice in septic shock is noradrenaline) , Hydrocortisone 100-200 mg/day is added In patients with refractory hypotension Obtain blood cultures before administration antibiotics. Control source of sepsis. Patients in group (A)were administered 5 mg ivabradine ( orally or crushed and injected through the enteral feeding tube every 12 hours.Heart rate was assessed prior to each dose.
Group (B): Patients didn't receive Ivabradine .
- Conditions
- Heart Rhythm Disorder
- Being tested
- Ivabradine 5mg Tab, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivabradine 5mg TabDrug
Ivabradine (5 mg twice daily) orally or via nasogastric tube
controlDrug
Patients didn't receive Ivabradine .
| Study group | Role | What they receive |
|---|---|---|
| Patients received Ivabradine | Active comparator | Not described Receives: Drug: Ivabradine 5mg Tab |
| Patients didn't receive Ivabradine . | Sham comparator | Not described Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients with heart rate reduction of at least 10 beats/min
Measured: after 72 hours of treatment
Secondary outcomes (3)
Mean heart rate
Measured: 72 hours of treatment
Mean arterial blood pressure
Measured: 72 hours of treatment
percentage of patients needed vasopressor
Measured: 72 hours of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rhythm DisorderStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742164
- Sponsor's protocol ID
- ms 719/2023
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ivabradine for Heart Rate Control in Management of Patients With Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT06742164
- Acronym / sponsor ID
- ms 719/2023
- Conditions
- Heart Rhythm Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Dec 2024 (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.
Tachycardia is associated with excess mortality during septic shock. This may be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function and less effect of administered exogenous catecholamines.
In this study, we evaluate the effect of enteral Ivabradine on outcome of septic patients regarding need for vasopressor therapy, mechanical ventilation, renal replacement therapy, length of ICU stay and in-hospital mortality.
Detailed description
All patients will be subjected to:
- Thorough history taking:
- Demographic data: age, sex and residence.
- Clinical presentation (fever, hypotension , tachycardia , tachypnea and anuria) .
- Family history of immunodeficiency disease
- History of recurrent
- Clinical examination:
- Vital signs: heart rate (HR) , blood pressure (BP), and temperature.
- Abdominal examination .
- Detect septic focus .
- Urine out put .
- Follow up until discharge from ICU.
- Laboratory investigations:
All patient will be screened with :
- Kidney function test .
- Liver function test.
- Total leukocyticcount was assessed immediately after admission to ICU and then every other day
- C-reactive protien was assessed immediately after admission to ICU and then every other day
- Broad-spectrum antibiotic and then according to cultures and sensitivity.
- Radiological investigation .
- Abdominal ultrasound.
- ECG.
- Echocardiography.
Study tools and procedures:
Epidemiological, demographic, clinical, laboratory, treatment, and outcome data will be obtained from medical records using a standardized data collection form.
Data will be obtained by Randomized controlled clinical trial (RCT) of medical records after, the study methodology reviewed and approved by the Research Review Board of Alhelal hospital (Intensive care unit), Faculty of medicine, Ain Shams University hospitals (Intensive care unit) .
The point of enrolment after initial haemodynamic stabilisation was taken as time 0. The following data sets were recorded at the specified time intervals.
An arterial line and central venous catheter were inserted in all patients for invasive blood pressure and central venous pressure monitoring. The point of enrolment after initial haemodynamic stabilisation was taken as time 0.
If the heart rate was less than 70 beats /min. the dose was omitted. The initial mangement of patients with sepsis and septic shock is summarised on three pillars of therapy.
Stabilization of haemodynamics with target mean arterial blood pressure at 65 mmHg for most patients, begain to rapidly administer 30ml/kg balanced crystalloid within 3 hours for hypotension or lactate ≥ 4mmol/L , Apply vasopressor if hypotensive during or after fluid resuscitation (The vasopressor of choice in septic shock is noradrenaline) , Hydrocortisone 100-200 mg/day is added In patients with refractory hypotension Obtain blood cultures before administration antibiotics. Control source of sepsis. Patients in group (A)were administered 5 mg ivabradine ( orally or crushed and injected through the enteral feeding tube every 12 hours.Heart rate was assessed prior to each dose.
Group (B): Patients didn't receive Ivabradine .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients received Ivabradine | Active comparator | Drug: Ivabradine 5mg Tab |
| Patients didn't receive Ivabradine . | Sham comparator | Drug: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with proven or suspected site of infection.
- Patients sepsis (acute organ dysfunction secondary to documented or suspected infection)
- Patients with septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure) for at least 6 hours and less than 24 hours.
- Patients with sinus rhythm with heart rate ≥ 95 bpm at time of randomization. Informed consent obtained in accordance with local regulations.
Key exclusion criteria (11 listed)
- Cardiac arrhythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), atrial fibrillation and heart block.
- Cardiogenic shock or acute heart failure, without proven or suspected infection.
- Acute coronary syndrome.
- Refractory shock with systolic arterial pressure <90 mm Hg despite the use of high doses of vasopressors.
- Co-treatment with drugs inducing bradycardia.
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 |
|---|---|---|
| Ivabradine 5mg TabIvabradine (5 mg twice daily) orally or via nasogastric tube | Drug | Patients received Ivabradine |
| controlPatients didn't receive Ivabradine . | Drug | Patients didn't receive Ivabradine . |
Primary outcome
the percentage of patients with heart rate reduction of at least 10 beats/min
Time frame: after 72 hours of treatment
3 secondary outcomes
Mean heart rate
Time frame: 72 hours of treatment
Mean arterial blood pressure
Time frame: 72 hours of treatment
percentage of patients needed vasopressor
Time frame: 72 hours of treatment
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 19 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ivabradine 5mg Tab in people with Heart Rhythm Disorder, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
the percentage of patients with heart rate reduction of at least 10 beats/min (time frame: after 72 hours of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.