Cerebral IschemiaNCT05294718
: External Shunt Versus Internal Shunt for Off Pump Glenn
A study testing Internal shunt and External shunt in people with Cerebral Ischemia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
A prospective, randomized comparative study where investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Cerebral Ischemia
- What is being tested?
- Internal shunt and External shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Aug 2022
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- single-ventricle lesions,
- good sized branch pulmonary arteries (Magoon's index > 1.5),
- PA pressures < 20 mmHg,
- So2 < 80%,
- age range from (6 months-5years)
- weight range from (6-21) kg, -All these patients had adequate atrial septal defects and none of these patients required any intra cardiac repair.-
Who cannot join
- previous cardiac operation,
- known intracranial pathology,
- neurologic disease
- craniofacial anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Shunt Versus Internal Shunt for Off Pump Glenn (Original Article)
A prospective, randomized comparative study where investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.
Read the detailed description
The bidirectional Glenn shunt (BDG) is performed for cyanotic congenital heart defects, with single-ventricle pathology . The BDG is usually performed with cardiopulmonary bypass (CPB) with its associated complications. The conduct of this operation without CPB can be associated with elevation of superior vena caval (SVC) pressure that may lead to neurological damage.
However, the safety of performing BDG without CPB reported by many authors but with some decompression techniques of the SVC at the time of clamping
Objective: investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.
Design A prospective, randomized comparative study Setting: Single tertiary care cardiac center Participants 30 patients with functional single ventricle who will go off pump bidirectional Glenn.
Interventions: The patients will be randomly assigned into two groups: Group I (n = 15), where it will be done with a veno-atrial shunt(internal), and Group II (n = 15), where it will be done with an external shunt. All patients will go a complete neurological examination both preoperatively as well as postoperatively Intraoperative data will be collected and analyzed at the following time points: pre-clamping (post induction), during clamping and after de-clamping of SVC. variables such as arterial oxygen saturation (SaO2), systolic blood pressure (SBP), mean arterial blood pressure (MAP), diastolic blood pressure (DBP), and hematocrit, CVP, SVC pressure, cerebral perfusion pressure (CPP= MAP-CVP), PaO2, PaCO2 and ScvO2 will be analyzed.
Postoperatively, the patients will be stabilized in the intensive care unit (ICU) and after monitoring the SVC pressure for 12 h, the internal jugular vein cannula will be removed to prevent any jugular vein thrombosis. The patients will start aspirin (5 mg/kg/day), which will be continued indefinitely.
- Conditions
- Cerebral Ischemia
- Being tested
- Internal shunt, External shunt
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal shuntProcedure or surgery
Also called Venoatrial shunt
glenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt.
External shuntProcedure or surgery
Also called Jagulo femoral shunt
Glenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension
| Study group | Role | What they receive |
|---|---|---|
| Internal shunt | Active comparator | glenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt. Receives: Procedure: Internal shunt |
| External shunt | Active comparator | Glenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension Receives: Procedure: External shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SVC Pressure
Measurment of superior vena cava pressure during off pumb Glenn
Measured: during SVC clamping procedure
Secondary outcomes (3)
mean ABP
Measurment of mean arterial blood preassure during off bumb Glenn
Measured: "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
cerebral perfusion pressure
CPP= MABP - CVP
Measured: "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
Mean SVC clamp time
Duration of SVC during off pump glenn with either Internal or external shunt
Measured: during SVC clamping procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Jun 2017
- Primary completion1 May 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral IschemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized comparative study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294718
- Sponsor's protocol ID
- MS-103-2013
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Shunt Versus Internal Shunt for Off Pump Glenn (Original Article)
- ClinicalTrials.gov ID
- NCT05294718
- Acronym / sponsor ID
- MS-103-2013
- Conditions
- Cerebral Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Mar 2022 (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.
A prospective, randomized comparative study where investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.
Detailed description
The bidirectional Glenn shunt (BDG) is performed for cyanotic congenital heart defects, with single-ventricle pathology . The BDG is usually performed with cardiopulmonary bypass (CPB) with its associated complications. The conduct of this operation without CPB can be associated with elevation of superior vena caval (SVC) pressure that may lead to neurological damage.
However, the safety of performing BDG without CPB reported by many authors but with some decompression techniques of the SVC at the time of clamping
Objective: investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.
Design A prospective, randomized comparative study Setting: Single tertiary care cardiac center Participants 30 patients with functional single ventricle who will go off pump bidirectional Glenn.
Interventions: The patients will be randomly assigned into two groups: Group I (n = 15), where it will be done with a veno-atrial shunt(internal), and Group II (n = 15), where it will be done with an external shunt. All patients will go a complete neurological examination both preoperatively as well as postoperatively Intraoperative data will be collected and analyzed at the following time points: pre-clamping (post induction), during clamping and after de-clamping of SVC. variables such as arterial oxygen saturation (SaO2), systolic blood pressure (SBP), mean arterial blood pressure (MAP), diastolic blood pressure (DBP), and hematocrit, CVP, SVC pressure, cerebral perfusion pressure (CPP= MAP-CVP), PaO2, PaCO2 and ScvO2 will be analyzed.
Postoperatively, the patients will be stabilized in the intensive care unit (ICU) and after monitoring the SVC pressure for 12 h, the internal jugular vein cannula will be removed to prevent any jugular vein thrombosis. The patients will start aspirin (5 mg/kg/day), which will be continued indefinitely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized comparative study
| Arm | Type | Receives |
|---|---|---|
| Internal shunt | Active comparator | Procedure: Internal shuntglenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt. |
| External shunt | Active comparator | Procedure: External shuntGlenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- single-ventricle lesions,
- good sized branch pulmonary arteries (Magoon's index > 1.5),
- PA pressures < 20 mmHg,
- So2 < 80%,
- age range from (6 months-5years)
Key exclusion criteria (4 listed)
- previous cardiac operation,
- known intracranial pathology,
- neurologic disease
- craniofacial anomalies.
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 |
|---|---|---|
| Internal shuntAlso: Venoatrial shuntglenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt. | Procedure or surgery | Internal shunt |
| External shuntAlso: Jagulo femoral shuntGlenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension | Procedure or surgery | External shunt |
Primary outcome
Mean SVC Pressure
Time frame: during SVC clamping procedure
Measurment of superior vena cava pressure during off pumb Glenn
3 secondary outcomes
mean ABP
Time frame: "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
cerebral perfusion pressure
Time frame: "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
Mean SVC clamp time
Time frame: during SVC clamping procedure
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 13 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal shunt and External shunt in people with Cerebral Ischemia, run by Kasr El Aini Hospital 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 6 inclusion and 4 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 13 Mar 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.
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?
Mean SVC Pressure (time frame: during SVC clamping procedure). 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 Mar 2023.