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Clinical Trials/NCT03146143
NCT03146143CompletedNot Applicable

Effect of Ultra Filtration on Extravascular Lung Water Assessed by Lung Ultrasound in Pediatric Cardiac Surgery

Kasr El Aini Hospital1 site in 1 country60 target enrollmentStarted: May 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Lung ultrasound score

Study Overview

Brief 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.

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%.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
1 Month to 4 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pediatrics undergoing congenital heart surgery
  • Age 1 months to 4 years
  • ASA II and III
  • Weight more than 3 kg

Exclusion Criteria

  • pre-operative mechanical ventilation
  • Pre-operative inotropic support.
  • Patients with lung disease (asthma, bronchiectasis)
  • Preoperative renal impairment (cr > 1.5mg/dl)

Arms & Interventions

ultrafiltration group

Experimental

ultrafiltration after cardiopulmonary bypass in congenital cardiac surgery

Intervention: ultrafiltration (Procedure)

non ultrafiltration control group

No Intervention

no ultrafiltration will be applied in this group

Outcomes

Primary Outcomes

Lung ultrasound score

Time Frame: at the end of surgery

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

Secondary Outcomes

  • ultrafiltration volume(at the end of surgery)
  • lung ultrasound score(baseline 5 minutes after induction of anesthesia)
  • duration of ventilation(up to 2 weeks)
  • creatinine(baseline, day 1 postoperative in icu. day 2 postoperative in icu)
  • P/F ratio(baseline 5 minutes after induction of anesthesia and at the end of surgery)
  • urea(baseline, day 1 postoperative in icu. day 2 postoperative in icu)

Investigators

Sponsor
Kasr El Aini Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Elayashy Mohamed Ahmed Hassan

clinical professor

Kasr El Aini Hospital

Study Sites (1)

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