Congenital Cardiac DisordersNCT03146143
Ultrafiltration Effect on Extravascular Lung Water in Pediatric Cardiac Surgery
A study testing ultrafiltration in people with Congenital Cardiac Disorders, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
study will assess the effect the ultrafiltration after pediatric congenital heart surgery on cardiopulmonary bypass. patients will be divided into two groups. first group will receive ultrafiltration and the second group will be control group without filtration. Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Congenital Cardiac Disorders
- What is being tested?
- ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2017to 15 Oct 2017
- 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 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatrics undergoing congenital heart surgery
- Age 1 months to 4 years
- ASA II and III
- Weight more than 3 kg
Who cannot join
- pre-operative mechanical ventilation
- Pre-operative inotropic support.
- Patients with lung disease (asthma, bronchiectasis)
- Preoperative renal impairment (cr > 1.5mg/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultra Filtration on Extravascular Lung Water Assessed by Lung Ultrasound in Pediatric Cardiac Surgery
study will assess the effect the ultrafiltration after pediatric congenital heart surgery on cardiopulmonary bypass. patients will be divided into two groups. first group will receive ultrafiltration and the second group will be control group without filtration.
we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and duration of ventilation.
Read the detailed description
The anesthesiologist will interview the guardians; examine the patients, checking all routine investigations include: CBC(complete blood count), coagulation profile, liver function tests, renal function tests, blood grouping, chest X-ray, recent echocardiography and angiography if available.
Children will be received Midazolam 0.3 mg/kg IM (intramuscular) and Atropine 0.02 mg/kg IM 10 min as pre-medication before induction.
Induction of anesthesia will be established using fentanyl, 1-5µg/kg, ketamine 1-2 g/kg. Atracurium 0.5mg/kg will be administered to facilitate endotracheal intubation and repeated intraoperative as required to maintain muscle relaxation. Anesthesia will be maintained using sevoflurane 0.3%-2 % in oxygen-air mixture (1:1 ratio). A central venous line will be inserted and arterial line for invasive blood pressure monitoring. The use of inotropes will be guided by the patient's hemodynamics after surgical repair. Dobutamine 5-10 µg/Kg/min, Tridil 1-4 µg/Kg/ min, Adrenaline 0.05µg/kg/min or Milrinone 0.5µg/kg/min will be used according to pathophysiology and Intraoperative state of patient.
In all patients, a median sternotomy will be performed. CPB will be initiated after full heparinization in a dose of 300-400 I.U to achieve a n ACT( activated clotting time) of 450 sec or 3 times baseline reading followed by the standard aorta-bicaval cannulation. A membrane oxygenator (Mini-max Plus; Medtronic Inc., Anaheim, CA) and a non-pulsatile roller pump (model 10.10.00; Stôckert Instruments; Munich, Germany) will be used. Venting of the left heart will be performed with a left atrial vent inserted through a small incision at the interatrial septum. Priming fluids consist of lactated Ringer's solution supplemented with heparin. Fresh whole blood was added to the priming solution in appropriate amounts to achieve a hematocrit of 20% to 22% during CPB ( cardiopulmonary bypass). Moderate hypothermia (26°C to 28°C) will be used during CPB.
After cardiac repair the patient will be weaned from CPB. protamine will be given 3-4 mg/kg to reverse heparin. The control group will not subjected to ultrafiltration and the ultrafiltration group will be subjected to conventional ultrafiltration guided by hematocrit level 28%.
Blood transfusion on bypass will be guided by hemoglobin level in ABG (arterial blood gases) to keep HB% (hemoglobin) above 7mg/dl. Transfusion of blood products will be guided by clinical state of patient.
Assessment of extra vascular lung water busing lung ultrasound. Lung ultrasound will be performed to diagnose EVLW (extravascular lung water). A M. turbo sonosite ultrasound system with pediatric linear probe (frequency 13-6 MHz( megahertz); Fujifilm, sonosite, inc. USA) will be used. Chest ultrasound will be performed using the 12 reg ions method. Intercostals spaces on each side will be examined anteriorly (midclavicular line), laterally (anterior axillary line) and posteriorly (posterior axillary line) (2).
Four ultrasound aeration patterns: a. Normal aeration (N): 0 score ; line sliding sign associated with respiratory movement or less than 3 B lines ; b. Moderate loss of lung aeration: score 1 ; a clear number of multiple visible B-lines with horizontal spacing between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung aeration: score 2; multiple B lines fused together that were difficult to count with horizontal spacing between adjacent B lines ≤ 3 mm (B3 lines); and d. Pulmonary consolidation: score 3; hypoechoic lung tissue, accompanied by dynamic air bronchogram.
The final LUS (lung ultrasound score) of the patient was the sum of each regional ultrasound score (ranging from 0 to 36).
The lung ultrasound score will be recorded at baseline and at end of surgery. ABGs will be taken to measure p/f ratio. Hemodynamic (HR and MAP) will be recorded.
- Conditions
- Congenital Cardiac Disorders
- Being tested
- ultrafiltration
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrafiltrationProcedure or surgery
ultrafiltration after cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| ultrafiltration group | Experimental | ultrafiltration after cardiopulmonary bypass in congenital cardiac surgery Receives: Procedure: ultrafiltration |
| non ultrafiltration control group | No intervention | no ultrafiltration will be applied in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound score
assess extravascular lung water in the form of B lines in lung ultrasound
Measured: at the end of surgery
Secondary outcomes (6)
lung ultrasound score
assess extravascular lung water in the form of B lines in lung ultrasound
Measured: baseline 5 minutes after induction of anesthesia
ultrafiltration volume
Measured: at the end of surgery
urea
Measured: baseline, day 1 postoperative in icu. day 2 postoperative in icu
duration of ventilation
Measured: up to 2 weeks
creatinine
Measured: baseline, day 1 postoperative in icu. day 2 postoperative in icu
P/F ratio
po2 measured by arterial blood gases and then divided by fio2 to get P/F ratio
Measured: baseline 5 minutes after induction of anesthesia and at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start15 May 2017
- Primary completion10 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Cardiac DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146143
- Sponsor's protocol ID
- N-19-2017
- Status last verified
- Jul 2018
- First submitted
- 29 Apr 2017
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.
PubMed 15888847Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian.
PubMed 18386121Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
PubMed 26298866Elayashy M, Madkour MA, Mahmoud AAA, Hosny H, Hussein A, Nabih A, Lofty A, Hamza HM, Hassan P, Wagih M, Mohamed AK. Effect of ultrafiltration on extravascular lung water assessed by lung ultrasound in children undergoing cardiac surgery: a randomized prospective study. BMC Anesthesiol. 2019 Jun 4;19(1):93. doi: 10.1186/s12871-019-0771-1.
PubMed 31159739
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultra Filtration on Extravascular Lung Water Assessed by Lung Ultrasound in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03146143
- Acronym / sponsor ID
- N-19-2017
- Conditions
- Congenital Cardiac Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 9 May 2017 (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.
study will assess the effect the ultrafiltration after pediatric congenital heart surgery on cardiopulmonary bypass. patients will be divided into two groups. first group will receive ultrafiltration and the second group will be control group without filtration.
we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and duration of ventilation.
Detailed description
The anesthesiologist will interview the guardians; examine the patients, checking all routine investigations include: CBC(complete blood count), coagulation profile, liver function tests, renal function tests, blood grouping, chest X-ray, recent echocardiography and angiography if available.
Children will be received Midazolam 0.3 mg/kg IM (intramuscular) and Atropine 0.02 mg/kg IM 10 min as pre-medication before induction.
Induction of anesthesia will be established using fentanyl, 1-5µg/kg, ketamine 1-2 g/kg. Atracurium 0.5mg/kg will be administered to facilitate endotracheal intubation and repeated intraoperative as required to maintain muscle relaxation. Anesthesia will be maintained using sevoflurane 0.3%-2 % in oxygen-air mixture (1:1 ratio). A central venous line will be inserted and arterial line for invasive blood pressure monitoring. The use of inotropes will be guided by the patient's hemodynamics after surgical repair. Dobutamine 5-10 µg/Kg/min, Tridil 1-4 µg/Kg/ min, Adrenaline 0.05µg/kg/min or Milrinone 0.5µg/kg/min will be used according to pathophysiology and Intraoperative state of patient.
In all patients, a median sternotomy will be performed. CPB will be initiated after full heparinization in a dose of 300-400 I.U to achieve a n ACT( activated clotting time) of 450 sec or 3 times baseline reading followed by the standard aorta-bicaval cannulation. A membrane oxygenator (Mini-max Plus; Medtronic Inc., Anaheim, CA) and a non-pulsatile roller pump (model 10.10.00; Stôckert Instruments; Munich, Germany) will be used. Venting of the left heart will be performed with a left atrial vent inserted through a small incision at the interatrial septum. Priming fluids consist of lactated Ringer's solution supplemented with heparin. Fresh whole blood was added to the priming solution in appropriate amounts to achieve a hematocrit of 20% to 22% during CPB ( cardiopulmonary bypass). Moderate hypothermia (26°C to 28°C) will be used during CPB.
After cardiac repair the patient will be weaned from CPB. protamine will be given 3-4 mg/kg to reverse heparin. The control group will not subjected to ultrafiltration and the ultrafiltration group will be subjected to conventional ultrafiltration guided by hematocrit level 28%.
Blood transfusion on bypass will be guided by hemoglobin level in ABG (arterial blood gases) to keep HB% (hemoglobin) above 7mg/dl. Transfusion of blood products will be guided by clinical state of patient.
Assessment of extra vascular lung water busing lung ultrasound. Lung ultrasound will be performed to diagnose EVLW (extravascular lung water). A M. turbo sonosite ultrasound system with pediatric linear probe (frequency 13-6 MHz( megahertz); Fujifilm, sonosite, inc. USA) will be used. Chest ultrasound will be performed using the 12 reg ions method. Intercostals spaces on each side will be examined anteriorly (midclavicular line), laterally (anterior axillary line) and posteriorly (posterior axillary line) (2).
Four ultrasound aeration patterns: a. Normal aeration (N): 0 score ; line sliding sign associated with respiratory movement or less than 3 B lines ; b. Moderate loss of lung aeration: score 1 ; a clear number of multiple visible B-lines with horizontal spacing between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung aeration: score 2; multiple B lines fused together that were difficult to count with horizontal spacing between adjacent B lines ≤ 3 mm (B3 lines); and d. Pulmonary consolidation: score 3; hypoechoic lung tissue, accompanied by dynamic air bronchogram.
The final LUS (lung ultrasound score) of the patient was the sum of each regional ultrasound score (ranging from 0 to 36).
The lung ultrasound score will be recorded at baseline and at end of surgery. ABGs will be taken to measure p/f ratio. Hemodynamic (HR and MAP) will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrafiltration group | Experimental | Procedure: ultrafiltrationultrafiltration after cardiopulmonary bypass in congenital cardiac surgery |
| non ultrafiltration control group | No intervention | –no ultrafiltration will be applied in this group |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatrics undergoing congenital heart surgery
- Age 1 months to 4 years
- ASA II and III
- Weight more than 3 kg
Key exclusion criteria (4 listed)
- pre-operative mechanical ventilation
- Pre-operative inotropic support.
- Patients with lung disease (asthma, bronchiectasis)
- Preoperative renal impairment (cr > 1.5mg/dl)
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 |
|---|---|---|
| ultrafiltrationultrafiltration after cardiopulmonary bypass | Procedure or surgery | ultrafiltration group |
Primary outcome
Lung ultrasound score
Time frame: at the end of surgery
assess extravascular lung water in the form of B lines in lung ultrasound
6 secondary outcomes
lung ultrasound score
Time frame: baseline 5 minutes after induction of anesthesia
ultrafiltration volume
Time frame: at the end of surgery
urea
Time frame: baseline, day 1 postoperative in icu. day 2 postoperative in icu
duration of ventilation
Time frame: up to 2 weeks
creatinine
Time frame: baseline, day 1 postoperative in icu. day 2 postoperative in icu
P/F ratio
Time frame: baseline 5 minutes after induction of anesthesia and at the end of surgery
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 24 Jul 2018.
- Background: PubMed 15888847Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.
- Background: PubMed 18386121Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian.
- Background: PubMed 26298866Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
- Derived from this study: PubMed 31159739Elayashy M, Madkour MA, Mahmoud AAA, Hosny H, Hussein A, Nabih A, Lofty A, Hamza HM, Hassan P, Wagih M, Mohamed AK. Effect of ultrafiltration on extravascular lung water assessed by lung ultrasound in children undergoing cardiac surgery: a randomized prospective study. BMC Anesthesiol. 2019 Jun 4;19(1):93. doi: 10.1186/s12871-019-0771-1.
- Individual participant dataSharing planned: Undecided
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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 ultrafiltration in people with Congenital Cardiac Disorders, 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 4 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 24 Jul 2018. 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?
Lung ultrasound score (time frame: at the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03146143, which also lists 4 linked publications.
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 24 Jul 2018.