Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO

NCT01157299 | Unknown DMC

• 1 other identifier: HULP-PI-800
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is

• To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI, GEF) and lung water indices (ELWI), as predictors of fluid responsiveness in both spontaneously breathing and mechanically ventilated pediatric patients.
• To assess the value of stroke volume and pulse pressure changes from femoral pulse contour analysis (PiCCO2) during passive leg raising as predictor of fluid responsiveness in pediatric patients.
• To establish normal and cutoff values of transpulmonary thermodilution (PiCCO2) hemodynamic variables in hemodynamically stables and hemodynamically "normal" patients.

Conditions

Shock; Sepsis; Systemic Inflammatory Response Syndrome; Low Cardiac Output; Dilated Cardiomyopathy

Keywords

Hemodynamics; Pediatric Intensive Care Unit; Low cardiac output; Thermodilution; Stroke volume; Global end-diastolic volume; Fluid responsiveness; Passive leg raising; Infant

Study Arms (3)

Hemodynamic instability

Hypotension and/or evidence of end-organ hypoperfusion

Hemodynamic stability

Normotension and end-organ normoperfusion along with * Vasopressor, vasodilator or inotropic therapy * Edema and/or evidence of hypervolemia

Hemodinamically "normal"

Normotension and end-organ normoperfusion along with * Non vasopressor, vasodilator or inotropic therapy * Normohydration state * Non Systemic Inflammatory Response Syndrome * Spontaneous breathing and PEEP, or CPAP, equal or less than 5 cm H2O

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients admitted to the PICU equipped with a femoral arterial catheter and a central venous catheter or who require advanced hemodinamic monitoring

You may qualify if:

• Pediatric patients admitted to PICU
• Patient equipped with a femoral arterial catheter and central venous catheter or who requires advanced hemodynamic monitoring
• Parents consent

You may not qualify if:

• Absolute
• Patient with left to right cardiac shunts
• Patient with extra-corporeal life support
• Less than 4 Kg body weight
• For passive leg raising procedure
• Patient with head trauma or intracranial hypertension
• Patient in prone position
• Patient who may not tolerate supine or Trendelenburg position: ej. Glenn procedure
• Patient with hip injury

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (7)

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital Infantil Universitario del Niño Jesús

Madrid, 28009, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28223, Spain

RECRUITING

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

RECRUITING

Hospital Clinico Universitario

Valencia, 46010, Spain

RECRUITING

Related Publications (16)

• Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6.

  PMID: 19325359 BACKGROUND

• Michard F, Descorps-Declere A, Lopes MR. Using pulse pressure variation in patients with acute respiratory distress syndrome. Crit Care Med. 2008 Oct;36(10):2946-8. doi: 10.1097/CCM.0b013e318187b6fd. No abstract available.

  PMID: 18812805 BACKGROUND

• Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.

  PMID: 17080001 BACKGROUND

• Lichtwarck-Aschoff M, Zeravik J, Pfeiffer UJ. Intrathoracic blood volume accurately reflects circulatory volume status in critically ill patients with mechanical ventilation. Intensive Care Med. 1992;18(3):142-7. doi: 10.1007/BF01709237.

  PMID: 1644961 BACKGROUND

• Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.

  PMID: 14605066 BACKGROUND

• Teboul JL, Monnet X. Prediction of volume responsiveness in critically ill patients with spontaneous breathing activity. Curr Opin Crit Care. 2008 Jun;14(3):334-9. doi: 10.1097/MCC.0b013e3282fd6e1e.

  PMID: 18467896 BACKGROUND

• Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.

  PMID: 18214429 BACKGROUND

• Heenen S, De Backer D, Vincent JL. How can the response to volume expansion in patients with spontaneous respiratory movements be predicted? Crit Care. 2006;10(4):R102. doi: 10.1186/cc4970.

  PMID: 16846530 BACKGROUND

• Kim HK, Pinsky MR. Effect of tidal volume, sampling duration, and cardiac contractility on pulse pressure and stroke volume variation during positive-pressure ventilation. Crit Care Med. 2008 Oct;36(10):2858-62. doi: 10.1097/CCM.0b013e3181865aea.

  PMID: 18766112 BACKGROUND

• Pinsky MR. Heart-lung interactions. Curr Opin Crit Care. 2007 Oct;13(5):528-31. doi: 10.1097/MCC.0b013e3282efad97.

  PMID: 17762231 BACKGROUND

• Cecchetti C, Stoppa F, Vanacore N, Barbieri MA, Raucci U, Pasotti E, Tomasello C, Marano M, Pirozzi N. Monitoring of intrathoracic volemia and cardiac output in critically ill children. Minerva Anestesiol. 2003 Dec;69(12):907-18. English, Italian.

  PMID: 14743122 BACKGROUND

• Cecchetti C, Lubrano R, Cristaldi S, Stoppa F, Barbieri MA, Elli M, Masciangelo R, Perrotta D, Travasso E, Raggi C, Marano M, Pirozzi N. Relationship between global end-diastolic volume and cardiac output in critically ill infants and children. Crit Care Med. 2008 Mar;36(3):928-32. doi: 10.1097/CCM.0B013E31816536F7.

  PMID: 18431282 BACKGROUND

• Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.

  PMID: 18259726 BACKGROUND

• Haque IU, Zaritsky AL. Analysis of the evidence for the lower limit of systolic and mean arterial pressure in children. Pediatr Crit Care Med. 2007 Mar;8(2):138-44. doi: 10.1097/01.PCC.0000257039.32593.DC.

  PMID: 17273118 BACKGROUND

• Brierley J, Peters MJ. Distinct hemodynamic patterns of septic shock at presentation to pediatric intensive care. Pediatrics. 2008 Oct;122(4):752-9. doi: 10.1542/peds.2007-1979.

  PMID: 18829798 BACKGROUND

• Slater A, Shann F, Pearson G; Paediatric Index of Mortality (PIM) Study Group. PIM2: a revised version of the Paediatric Index of Mortality. Intensive Care Med. 2003 Feb;29(2):278-85. doi: 10.1007/s00134-002-1601-2. Epub 2003 Jan 23.

  PMID: 12541154 BACKGROUND

MeSH Terms

Conditions

Shock; Sepsis; Systemic Inflammatory Response Syndrome; Cardiac Output, Low; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Inflammation; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pedro de la Oliva, MD PhD.

  Hospital Universitario La Paz

  STUDY DIRECTOR

• Ignacio Sánchez-Díaz, MD PhD

  Hospital Universitario 12 de Octubre de Madrid

  PRINCIPAL INVESTIGATOR

• Elena Alvarez-Rojas, MD

  Hospital Universitario Ramón y Cajal de Madrid

  PRINCIPAL INVESTIGATOR

• Susana Jaraba-Caballero, MD

  Hospital Universitario Reina Sofia de Córdoba

  PRINCIPAL INVESTIGATOR

• Patricia Roselló-Millet, MD

  Hospital Clínico Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• José Manuel González-Gómez, MD

  Hospital Universitario Carlos Haya de Málaga

  PRINCIPAL INVESTIGATOR

• Ana Serrano-Gonzalez, MD PhD

  Hospital Infantil Universitario del Niño Jesús

  PRINCIPAL INVESTIGATOR

• Eduardo Consuegra-Llapur, MD

  Hospital Universitario Materno-Infantil de las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro de la Oliva, MD PhD

CONTACT

+34917277149; poliva.hulp@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 7, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-06

Locations

ES (7)