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Circulatory Changes During Venovenous (VV)- and Venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) (ECMO)

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ClinicalTrials.gov Identifier: NCT00622492
Recruitment Status : Unknown
Verified February 2008 by Radboud University.
Recruitment status was:  Recruiting
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
Sponsor:
Information provided by:
Radboud University

Brief Summary:

Rationale: Persistent pulmonary hypertension of the newborn (PPHN) is a life threatening disease with a high mortality rate. Extracorporeal Membrane Oxygenation (ECMO) with veno-arterial (V-A) or veno-venous (V-V) cannulation can provide a last treatment option. Differences in circulatory changes between V-A and V-V ECMO concerning the course of PPHN and organ perfusion are not known. Independent of the underlying disease, courses of ECMO runs (with both systems) may differ a lot. Impairment of pulmonary and renal function and oedema is frequently seen. Mechanisms that may play a role are not well understood yet. A better understanding of hemodynamic changes in systemic and pulmonary circulation during treatment of PPHN with ECMO as well as consecutive changes in organ perfusion and function will help to develop more rationalistic treatment strategies to accelerate the recovery to a normal neonatal circulation and shorten ECMO treatment. This will reveal positive effects for patients as well as favourable effects on economic aspects for this very intensive treatment.

Primary objective: I.Evaluation of changes in pulmonary and systemic circulation during VV- ECMO treatment and difference between V-V- and V-A ECMO Secondary objectives:II.Evaluation of changes in cerebral, renal and mesenterial organ perfusion during ECMO treatment and difference between V-V- and V-A ECMO III.Evaluation of hemodynamic changes during ECMO treatment in relation to renal function and difference between V-V- and V-A ECMO IV.Evaluation of BNP as diagnostic parameter regarding fluid homeostasis during ECMO treatment and difference between V-V- and V-A ECMO Study design: observational; including two cohorts. The first cohort consists of a group of patients that have been evaluated in a former study, exclusively treated with V-A ECMO. The second cohort of patients will prospectively include patients receiving V-V as well as V-A ECMO. A study period:2 and a half years. All consecutively admitted patients for ECMO treatment at the department of neonatology of the RUNMC will be evaluated for inclusion into the study. Study population: Inclusion: Newborn infants with gestational age older than 34 weeks and reversible causes of PPHN eligible for ECMO treatment. Exclusion:Newborn infants with congenital diaphragmatic hernia, other congenital malformations and post-cardiosurgery.

Intervention: Standard treatment following the ECMO protocol of the department; evaluation at standard intervals starting directly before cannulation for ECMO until 24 hours after decannulation:registration of hemodynamic variables,parameters for organ perfusion using echocardiography and Doppler sonography, blood and urine sampling and registration of physiological and patient data.

Main study parameters/endpoints: Assessment of:Hemodynamic changes in pulmonary and systemic circulation Secondary and other parameters/endpoints:

Assessment of:Changes in cerebral, renal and mesenterial blood flow, renal function in relation hemodynamic changes,BNP in relation to fluid homeostasis


Condition or disease Intervention/treatment
Pulmonary Hypertension of the Newborn (PPHN) Other: echocardiography Doppler sonography, blood and urine sampling

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ECMO in Newborn Infants: Circulatory Changes in Relation to Venovenous and Venoarterial Bypass. Implications for Peripheral Organ Circulation
Study Start Date : January 2008
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Group/Cohort Intervention/treatment
VV-ECMO
newborn infants with reversible causes of PPHN eligible for ECMO treatment
Other: echocardiography Doppler sonography, blood and urine sampling
data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO
VA-ECMO
newborn infants with reversible causes of PPHN eligible for ECMO treatment
Other: echocardiography Doppler sonography, blood and urine sampling
data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO



Biospecimen Retention:   Samples Without DNA
whole blood, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
newborn infants with PPHN admitted to the NICU Radboud University Medical Centre for ECMO treatment consecutive patient sampling
Criteria

Inclusion Criteria:

  • Reversible cause of PPHN
  • Newborn infant
  • Older 34 weeks gestational age

Exclusion Criteria:

  • Congenital diaphragmatic hernia
  • Congenital malformation
  • Post-cardiosurgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622492


Contacts
Contact: V Christmann, MD 0031243613936 v.christmann@cukz.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: V Christmann, MD    0031243613936    v.christmann@cukz.umcn.nl   
Principal Investigator: R. de Groot, prof. dr.         
Sponsors and Collaborators
Radboud University

Publications:
Responsible Party: V. Christmann, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00622492     History of Changes
Other Study ID Numbers: 2007/219
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 25, 2008
Last Verified: February 2008

Keywords provided by Radboud University:
VV-ECMO
VA-ECMO
PPHN
organ circulation

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases