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Ultrafiltration Effect on Extravascular Lung Water in Pediatric Cardiac Surgery

Primary Purpose

Congenital Cardiac Disorders

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrafiltration
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Cardiac Disorders

Eligibility Criteria

1 Month - 4 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kasr Alainy Hospital , Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ultrafiltration group

non ultrafiltration control group

Arm Description

ultrafiltration after cardiopulmonary bypass in congenital cardiac surgery

no ultrafiltration will be applied in this group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

lung ultrasound score
assess extravascular lung water in the form of B lines in lung ultrasound
ultrafiltration volume
urea
duration of ventilation
creatinine
P/F ratio
po2 measured by arterial blood gases and then divided by fio2 to get P/F ratio

Full Information

First Posted
April 29, 2017
Last Updated
July 20, 2018
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03146143
Brief Title
Ultrafiltration Effect on Extravascular Lung Water in Pediatric Cardiac Surgery
Official Title
Effect of Ultra Filtration on Extravascular Lung Water Assessed by Lung Ultrasound in Pediatric Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cardiac Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrafiltration group
Arm Type
Experimental
Arm Description
ultrafiltration after cardiopulmonary bypass in congenital cardiac surgery
Arm Title
non ultrafiltration control group
Arm Type
No Intervention
Arm Description
no ultrafiltration will be applied in this group
Intervention Type
Procedure
Intervention Name(s)
ultrafiltration
Intervention Description
ultrafiltration after cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Lung ultrasound score
Description
assess extravascular lung water in the form of B lines in lung ultrasound
Time Frame
at the end of surgery
Secondary Outcome Measure Information:
Title
lung ultrasound score
Description
assess extravascular lung water in the form of B lines in lung ultrasound
Time Frame
baseline 5 minutes after induction of anesthesia
Title
ultrafiltration volume
Time Frame
at the end of surgery
Title
urea
Time Frame
baseline, day 1 postoperative in icu. day 2 postoperative in icu
Title
duration of ventilation
Time Frame
up to 2 weeks
Title
creatinine
Time Frame
baseline, day 1 postoperative in icu. day 2 postoperative in icu
Title
P/F ratio
Description
po2 measured by arterial blood gases and then divided by fio2 to get P/F ratio
Time Frame
baseline 5 minutes after induction of anesthesia and at the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Kasr Alainy Hospital , Faculty of Medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15888847
Citation
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.
Results Reference
background
PubMed Identifier
18386121
Citation
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.
Results Reference
background
PubMed Identifier
26298866
Citation
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.
Results Reference
background
PubMed Identifier
31159739
Citation
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.
Results Reference
derived

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Ultrafiltration Effect on Extravascular Lung Water in Pediatric Cardiac Surgery

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