Elective Cardiac SurgeryPhase 4NCT01418521
Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery
A Phase 4 study testing Balanced hydroxyethyl starch solution and Ringer- albumin in people with Elective Cardiac Surgery, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Cardiac Surgery
- What is being tested?
- Balanced hydroxyethyl starch solution and Ringer- albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Aug 2013
- Phase
- Phase 4
- 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
- Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed.
- Male or Female subject, 18 years or older.
- Any elective cardiac surgery
Who cannot join
- Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L.
- Hyperhydration states (e.g. pulmonary edema, congestive heart failure).
- Renal failure with creatinine blood levels > 2.5 mg/dL or eGFR < 30 ml/min (calculated using the DMRD formula).
- Oliguria (UO<0.5ml\kg\hr) or anuria (not related to hypovolemia) more than 12 hours.
- Current Intracranial hemorrhage.
- Current, hard to balance hyperkalemia.
- Severe hypernatremia or severe hyperchloremia.
- Known hypersensitivity to hydroxyethyl starch or to any of the excipients.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam health care campus
Haifa
Liran Shani, MD, l_shani@rambam.health.gov.il
About this study
Official title: Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery
The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.
- Conditions
- Elective Cardiac Surgery
- Being tested
- Balanced hydroxyethyl starch solution, Ringer- albumin
- Keywords
- Cardiac surgery, Balanced 3rd generation Hydroxyethyl starch, Tetraspan, Ringer-albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced hydroxyethyl starch solutionDrug
Also called Tetraspan
Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.
Ringer- albuminDrug
Also called HARTMANN Solution, Human albumin 20%- Zenalb
Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Ringer-albumin | Active comparator | Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery Receives: Drug: Ringer- albumin |
| Tetraspan | Experimental | patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery Receives: Drug: Balanced hydroxyethyl starch solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube drainage volume
Measured: Total volume at the time of removal of drains (48 hours after surgery on average)
Secondary outcomes (6)
Volume of replacement fluids given after surgery at each group
Measured: Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average)
In hospital - all cause mortality
Measured: End of hospitalization (5 days postsurgery on average)
30-days all cause mortality
Measured: 30 days from surgery
Incidence of kidney injury as defined by RIFLE criteria
Measured: Duration of hospitalization after surgery (expected average duration of 5 days)
Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization.
Measured: Duration of hospitalization after surgery (expected average duration of 5 days)
Volume of Transfused blood products during hospitalization postsurgery
Measured: Duration of hospitalization after surgery (expected average duration of 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cardiac SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Zvi Adler, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418521
- Sponsor's protocol ID
- RMB-0058.CTIL
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01418521
- Acronym / sponsor ID
- RMB-0058.CTIL
- Conditions
- Elective Cardiac Surgery
- Keywords
- Cardiac surgery, Balanced 3rd generation Hydroxyethyl starch, Tetraspan, Ringer-albumin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 17 Aug 2011 (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 purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer-albumin | Active comparator | Drug: Ringer- albuminPatients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery |
| Tetraspan | Experimental | Drug: Balanced hydroxyethyl starch solutionpatients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed.
- Male or Female subject, 18 years or older.
- Any elective cardiac surgery
Key exclusion criteria (8 listed)
- Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L.
- Hyperhydration states (e.g. pulmonary edema, congestive heart failure).
- Renal failure with creatinine blood levels > 2.5 mg/dL or eGFR < 30 ml/min (calculated using the DMRD formula).
- Oliguria (UO<0.5ml\kg\hr) or anuria (not related to hypovolemia) more than 12 hours.
- Current Intracranial hemorrhage.
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 |
|---|---|---|
| Balanced hydroxyethyl starch solutionAlso: TetraspanPatients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed. | Drug | Tetraspan |
| Ringer- albuminAlso: HARTMANN Solution, Human albumin 20%- ZenalbPatients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery | Drug | Ringer-albumin |
Primary outcome
Chest tube drainage volume
Time frame: Total volume at the time of removal of drains (48 hours after surgery on average)
6 secondary outcomes
Volume of replacement fluids given after surgery at each group
Time frame: Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average)
In hospital - all cause mortality
Time frame: End of hospitalization (5 days postsurgery on average)
30-days all cause mortality
Time frame: 30 days from surgery
Incidence of kidney injury as defined by RIFLE criteria
Time frame: Duration of hospitalization after surgery (expected average duration of 5 days)
Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization.
Time frame: Duration of hospitalization after surgery (expected average duration of 5 days)
Volume of Transfused blood products during hospitalization postsurgery
Time frame: Duration of hospitalization after surgery (expected average duration of 5 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
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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.
Zvi Adler, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balanced hydroxyethyl starch solution and Ringer- albumin in people with Elective Cardiac Surgery, run by Rambam Health Care Campus at 1 site in Israel.
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 8 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: status not confirmed, as of the sponsor's last update on 17 Aug 2011. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liran Shani, MD (972-8542631, l_shani@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest tube drainage volume (time frame: Total volume at the time of removal of drains (48 hours after surgery on average)). 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 17 Aug 2011.