Anemia Treatment Among Patients Suffering From Left Ventricular Systolic DysfunctionNCT01705470
Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction
A study testing furosemide in people with Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction
- What is being tested?
- furosemide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jun 2013
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is over 18 years old.
- Documented ejection function equal to or over 40% in prior tests
- The treating physician decided to treat the patient with packed cell
Who cannot join
- Known hypersensitivity to furosemide.
- Calculated creatinine clearance over 20% (by MDRD)
- Past adverse reaction to blood product.
About this study
The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide
Read the detailed description
More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.
Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.
- Being tested
- furosemide, placebo normal saline
- Keywords
- Furosemide, Anemia, LV dysfunction, blood transfusion
- Medical subject headings
- Anemia, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemideDrug
placebo normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| arm1 | Experimental | will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells). Receives: Drug: furosemide |
| arm2 | Experimental | will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells). Receives: Drug: placebo normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment
Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment
Measured: Within 4 hours from receiving the blood transfusion
Secondary outcomes (1)
clinical outcome following blood transfusion, with or without Furosemide treatment
clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation
Measured: Within 4 hours from receiving the blood transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: PI left the medical center, no replacement assigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia Treatment Among Patients Suffering From Left Ventricular Systolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Edo Birati, MD, Principal investigator, Tel Aviv MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705470
- Sponsor's protocol ID
- SHERLOCK
- Status last verified
- Jun 2016
- First submitted
- 9 Oct 2012
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction
- ClinicalTrials.gov ID
- NCT01705470
- Acronym / sponsor ID
- SHERLOCK
- Keywords
- Furosemide, Anemia, LV dysfunction, blood transfusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the medical center, no replacement assigned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide
Detailed description
More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.
Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm1 | Experimental | Drug: furosemidewill receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells). |
| arm2 | Experimental | Drug: placebo normal salinewill receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is over 18 years old.
- Documented ejection function equal to or over 40% in prior tests
- The treating physician decided to treat the patient with packed cell
Key exclusion criteria (3 listed)
- Known hypersensitivity to furosemide.
- Calculated creatinine clearance over 20% (by MDRD)
- Past adverse reaction to blood product.
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 |
|---|---|---|
| furosemide | Drug | arm1 |
| placebo normal saline | Drug | arm2 |
Primary outcome
Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment
Time frame: Within 4 hours from receiving the blood transfusion
Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment
1 secondary outcome
clinical outcome following blood transfusion, with or without Furosemide treatment
Time frame: Within 4 hours from receiving the blood transfusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Individual participant dataSharing planned: No
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.
Edo Birati, MD principal investigator
Tel Aviv MC
Questions about this trial
What is this clinical trial studying?
A study testing furosemide in people with Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction, run by Tel-Aviv Sourasky Medical Center.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Jun 2016. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment (time frame: Within 4 hours from receiving the blood transfusion). 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 28 Jun 2016.