Acute Normovolemic HemodilutionNCT04042883
Acute Normovolemic Hemodilution in Off-pump CABG
A study testing Acute normovolemic hemodilution in people with Acute Normovolemic Hemodilution and Off-Pump Coronary Artery Bypass Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
To study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Normovolemic Hemodilution, Off-Pump Coronary Artery Bypass Surgery
- What is being tested?
- Acute normovolemic hemodilution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2019to 15 Apr 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for off- pump CABG surgery
Who cannot join
- Ejection fraction less than 40%
- Hematocrit less than 11 g/dl
- patients with severe renal impairment
Trial locations and contacts
1 site in 1 country.
Fatma N. Mohamed, M.D. contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Hany M. Osman, M.D., +201002414591, hanymeo@gmail.com
Fatma N. Mohamed, M.D., fatmanabil2012@gmail.com
About this study
Official title: Acute Normovolemic Hemodilution Using Hydroxyethyl Starch (HES 130/0.4) in Patients Undergoing Off-pump Coronary Artery Bypass Grafting Surgery: Effects on Central and Peripheral Perfusion
To study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery
Read the detailed description
Off-pump coronary artery bypass surgery is an alternative to conventional coronary artery bypass grafting using cardiopulmonary bypass (CPB). It avoids adverse effects of CPB such as systemic inflammatory response, impaired myocardial protection, and air or plaque embolism. However, OPCAB surgery involves displacement and manipulation of the heart to expose target coronary arteries. These manipulations cause hemodynamic instability as a result of transient annulo-mitral distortion and acute mitral regurgitation, compression of the right ventricle, and impaired cardiac contractility due to epicardial stabilizers. signs of impaired perfusion such as metabolic acidosis, increased serum lactate and decreased urine output are commonly seen intraoperatively
Excessive surgical bleeding causes hypovolemia and hemodynamic instability, anemia, and reduced oxygen delivery to tissues
Acute normovolemic hemodilution (ANH) is an alternative method of management of intraoperative blood loss, in which a certain volume of blood is collected from the patient, stored at room temperature and replaced by an equal volume of colloid solution. By the end of surgery, this blood is returned to the patient, usually within eight hours of collection, with little deterioration of platelets or coagulation factors
This work aims to study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery
- Being tested
- Acute normovolemic hemodilution
- Keywords
- Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute normovolemic hemodilutionProcedure or surgery
Also called ANH
500 ml of blood will be taken from the patient with simultaneous replacement with hydroxyethyl starch (HES 130/0.4) in another IV line
| Study group | Role | What they receive |
|---|---|---|
| ANH | Active comparator | 500 ml of blood will be taken from the patient with simultaneous replacement with hydroxyethyl starch (HES 130/0.4) in another IV line Receives: Procedure: Acute normovolemic hemodilution |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central venous oxygen saturation
Central venous blood gas analysis
Measured: Intraoperative
The perfusion index
perfusion index derived from pulseoximetry
Measured: Intraoperative
Serum lactate
from arterial blood gas analysis
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start10 Aug 2019
- Primary completion15 Apr 2020 (estimated)
- Study completion15 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Normovolemic HemodilutionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mostafa Esmaeil Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042883
- Sponsor's protocol ID
- Hemodilution off-pump CABG
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 13 Aug 2019
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Normovolemic Hemodilution Using Hydroxyethyl Starch (HES 130/0.4) in Patients Undergoing Off-pump Coronary Artery Bypass Grafting Surgery: Effects on Central and Peripheral Perfusion
- ClinicalTrials.gov ID
- NCT04042883
- Acronym / sponsor ID
- Hemodilution off-pump CABG
- Keywords
- Perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 15 Apr 2020 (estimated)
- First posted
- 2 Aug 2019 (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.
To study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting surgery
Detailed description
Off-pump coronary artery bypass surgery is an alternative to conventional coronary artery bypass grafting using cardiopulmonary bypass (CPB). It avoids adverse effects of CPB such as systemic inflammatory response, impaired myocardial protection, and air or plaque embolism. However, OPCAB surgery involves displacement and manipulation of the heart to expose target coronary arteries. These manipulations cause hemodynamic instability as a result of transient annulo-mitral distortion and acute mitral regurgitation, compression of the right ventricle, and impaired cardiac contractility due to epicardial stabilizers. signs of impaired perfusion such as metabolic acidosis, increased serum lactate and decreased urine output are commonly seen intraoperatively
Excessive surgical bleeding causes hypovolemia and hemodynamic instability, anemia, and reduced oxygen delivery to tissues
Acute normovolemic hemodilution (ANH) is an alternative method of management of intraoperative blood loss, in which a certain volume of blood is collected from the patient, stored at room temperature and replaced by an equal volume of colloid solution. By the end of surgery, this blood is returned to the patient, usually within eight hours of collection, with little deterioration of platelets or coagulation factors
This work aims to study the effects of Acute normovolemic hemodilution on central and peripheral perfusion in patients Undergoing off-pump coronary artery bypass grafting 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 |
|---|---|---|
| ANH | Active comparator | Procedure: Acute normovolemic hemodilution500 ml of blood will be taken from the patient with simultaneous replacement with hydroxyethyl starch (HES 130/0.4) in another IV line |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for off- pump CABG surgery
Key exclusion criteria (3 listed)
- Ejection fraction less than 40%
- Hematocrit less than 11 g/dl
- patients with severe renal impairment
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 |
|---|---|---|
| Acute normovolemic hemodilutionAlso: ANH500 ml of blood will be taken from the patient with simultaneous replacement with hydroxyethyl starch (HES 130/0.4) in another IV line | Procedure or surgery | ANH |
Primary outcome
Central venous oxygen saturation
Time frame: Intraoperative
Central venous blood gas analysis
The perfusion index
Time frame: Intraoperative
perfusion index derived from pulseoximetry
Serum lactate
Time frame: Intraoperative
from arterial blood gas analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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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.
Fatma N. Mohamed, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute normovolemic hemodilution in people with Acute Normovolemic Hemodilution and Off-Pump Coronary Artery Bypass Surgery, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. 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.
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 Hany M. Osman, M.D. (+201002414591, hanymeo@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central venous oxygen saturation (time frame: Intraoperative). The study lists 3 primary outcomes in all. 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 13 Aug 2019.