NCT03146143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

April 29, 2017

Last Update Submit

July 20, 2018

Conditions

Congenital Cardiac Disorders

Outcome Measures

Primary Outcomes (1)

  • Lung ultrasound score

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

    at the end of surgery

Secondary Outcomes (6)

  • lung ultrasound score

    baseline 5 minutes after induction of anesthesia

  • ultrafiltration volume

    at the end of surgery

  • urea

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

  • duration of ventilation

    up to 2 weeks

  • creatinine

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

  • +1 more secondary outcomes

Study Arms (2)

ultrafiltration group

EXPERIMENTAL

ultrafiltration after cardiopulmonary bypass in congenital cardiac surgery

Procedure: ultrafiltration

non ultrafiltration control group

NO INTERVENTION

no ultrafiltration will be applied in this group

Interventions

ultrafiltrationPROCEDURE

ultrafiltration after cardiopulmonary bypass

ultrafiltration group

Eligibility Criteria

Age1 Month - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 15888847BACKGROUND

  • 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.

    PMID: 18386121BACKGROUND

  • 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.

    PMID: 26298866BACKGROUND

  • 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.

    PMID: 31159739DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Extracorporeal CirculationSurgical Procedures, OperativeFiltrationChemistry Techniques, AnalyticalInvestigative TechniquesPhysical PhenomenaChemical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 29, 2017

First Posted

May 9, 2017

Study Start

May 15, 2017

Primary Completion

October 10, 2017

Study Completion

October 15, 2017

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations

EG(1)