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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Kasr Alainy Hospital , Faculty of Medicine

    Cairo

Other trials in Egypt

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.

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 groups in NCT03146143
Study groupRoleWhat they receive
ultrafiltration groupExperimentalultrafiltration after cardiopulmonary bypass in congenital cardiac surgery
Receives: Procedure: ultrafiltration
non ultrafiltration control groupNo interventionno ultrafiltration will be applied in this group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. lung ultrasound score

    assess extravascular lung water in the form of B lines in lung ultrasound

    Measured: baseline 5 minutes after induction of anesthesia

  2. ultrafiltration volume

    Measured: at the end of surgery

  3. urea

    Measured: baseline, day 1 postoperative in icu. day 2 postoperative in icu

  4. duration of ventilation

    Measured: up to 2 weeks

  5. creatinine

    Measured: baseline, day 1 postoperative in icu. day 2 postoperative in icu

  6. 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.

  1. First posted9 May 2017
  2. Study start15 May 2017
  3. Primary completion10 Oct 2017
  4. Study completion15 Oct 2017

Resources

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)
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 15888847
  • Copetti 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 18386121
  • Zhao 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 26298866
  • Elayashy 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

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.

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