ShockPreloaDrenNCT01157299
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
An observational study of Shock and Sepsis, run by Hospital Universitario La Paz at 7 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Shock, Sepsis, Systemic Inflammatory Response Syndrome
- How many people
- 100 participants
- Where
- 7 sitesSpain
- Study dates
- Sep 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Pediatric patients admitted to PICU
- Patient equipped with a femoral arterial catheter and central venous catheter or who requires advanced hemodynamic monitoring
- Parents consent
Who cannot join
- 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
Show all 9Show fewer
- Patient in prone position
- Patient who may not tolerate supine or Trendelenburg position: ej. Glenn procedure
- Patient with hip injury
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
Susana Jaraba-Caballero, MD, sjaraba@gmail.com
Susana Jaraba-Caballero, MD
- Recruiting
Hospital Infantil Universitario del Niño Jesús
Madrid, 28009
Ana Serrano, MD PhD, aserrano.hnjs@salud.madrid.org
Ana Serrano, MD PhD
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Maria Elena Alvarez-Rojas, MD, alvarojas@hotmail.com
Maria Elena Alvarez-Rojas, MD
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Ignacio Sanchez-Diaz, MD PhD, jsanchezd.hdoc@salud.madrid.org
Ignacio Sanchez-Diaz, MD PhD
- Recruiting
Hospital Universitario La Paz
Madrid, 28223
Pedro de la Oliva, MD PhD, +34917277149, poliva.hulp@salud.madrid.org
Juan Jose Fernandez-Suso, MD, +34917277149, juanjomen@yahoo.es
- Recruiting
Hospital Regional Universitario Carlos Haya
Málaga, 29010
Jose Manuel Gonzalez-Gomez, MD, josemagogo@hotmail.com
Jose Manuel Gonzalez-Gomez, MD
- Recruiting
Hospital Clinico Universitario
Valencia, 46010
Patricia Roselló-Millet, MD, rosello_pat@gva.es
Patricia Roselló-Millet, MD
About this study
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.
Read the detailed description
One of the ongoing challenges in critical care has been determining adequate fluid resuscitation. Overly aggressive volume expansion may produce deleterious effects, especially in patients with respiratory, renal and/or cardiac failure. Since the clinical ability to judge hemodynamic parameters is known to be poor, the determination of variables that would predict response to fluid challenge would be important for clinical decision-making.
Traditional measures of preload (CVP, PAOP) are now known to be incapable to assess the volume status and fluid responsiveness, especially in children.
There are two kinds of reasons for explaining the failure of markers of preload to predict volume responsiveness: the first reason is that the markers commonly used at the bedside are not always accurate measures of cardiac preload; the second reason is that an assessment of preload is not an assessment of preload responsiveness.
The rapid determination of hemodynamic status offered by noninvasive hemodynamic devices as PICCO2 would allow tailoring of volume expansion necessary in hypoperfusion states to increase left ventricular volume and cardiac output. Studies in critically ill adults patients have demonstrated that passive leg raising autotransfusion and functional hemodynamic monitoring, by using pulse contour analysis, are reliable in the detection of fluid responsiveness. However, currently we have very few studies in pediatric patients using arterial pulse contour analysis and transpulmonary thermodilution, which does not allow the rational application of the hemodynamic variables for guiding fluid resuscitation.
This study pretend to assess 1) the value of dynamics and static indices of preload, and its combination with contractility and lung water indices, as predictors of fluid responsiveness in both spontaneously breathing and mechanically ventilated pediatric patients and 2) the value of stroke volume and pulse pressure changes during passive leg raising autotransfusion, as predictors of fluid responsiveness in pediatric patients.
In this observational study, the hemodynamical variables are registered during the hemodynamically unstable, stable and "normal" states of the pediatric patient and before and after clinically indicated fluid (crystalloid, colloid or hemoderivative) infusion. Passive leg raising hemodynamic changes will be compared with the hemodynamic changes caused by fluid infusion.
- 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
- Medical subject headings
- Shock, Sepsis, Systemic Inflammatory Response Syndrome, Cardiac Output, Low, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Investigators
- Pedro de la Oliva, MD PhD., Study director, Hospital Universitario La PazIgnacio Sánchez-Díaz, MD PhD, Principal investigator, Hospital Universitario 12 de Octubre de MadridElena Alvarez-Rojas, MD, Principal investigator, Hospital Universitario Ramón y Cajal de MadridSusana Jaraba-Caballero, MD, Principal investigator, Hospital Universitario Reina Sofia de CórdobaPatricia Roselló-Millet, MD, Principal investigator, Hospital Clínico Universitario de ValenciaJosé Manuel González-Gómez, MD, Principal investigator, Hospital Universitario Carlos Haya de MálagaAna Serrano-Gonzalez, MD PhD, Principal investigator, Hospital Infantil Universitario del Niño JesúsEduardo Consuegra-Llapur, MD, Principal investigator, Hospital Universitario Materno-Infantil de las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157299
- Sponsor's protocol ID
- HULP-PI-800
- Acronym
- PreloaDren
- Status last verified
- Jun 2010
- First submitted
- 6 Jul 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19325359Michard 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.
PubMed 18812805Osman 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.
PubMed 17080001Lichtwarck-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.
PubMed 1644961Michard 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.
PubMed 14605066Teboul 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.
PubMed 18467896Monnet 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.
PubMed 18214429Heenen 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.
PubMed 16846530Kim 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.
PubMed 18766112Pinsky MR. Heart-lung interactions. Curr Opin Crit Care. 2007 Oct;13(5):528-31. doi: 10.1097/MCC.0b013e3282efad97.
PubMed 17762231Cecchetti 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.
PubMed 14743122Cecchetti 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.
PubMed 18431282Durand 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.
PubMed 18259726Haque 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.
PubMed 17273118Brierley 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.
PubMed 18829798
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
- ClinicalTrials.gov ID
- NCT01157299
- Acronym / sponsor ID
- PreloaDren / HULP-PI-800
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One of the ongoing challenges in critical care has been determining adequate fluid resuscitation. Overly aggressive volume expansion may produce deleterious effects, especially in patients with respiratory, renal and/or cardiac failure. Since the clinical ability to judge hemodynamic parameters is known to be poor, the determination of variables that would predict response to fluid challenge would be important for clinical decision-making.
Traditional measures of preload (CVP, PAOP) are now known to be incapable to assess the volume status and fluid responsiveness, especially in children.
There are two kinds of reasons for explaining the failure of markers of preload to predict volume responsiveness: the first reason is that the markers commonly used at the bedside are not always accurate measures of cardiac preload; the second reason is that an assessment of preload is not an assessment of preload responsiveness.
The rapid determination of hemodynamic status offered by noninvasive hemodynamic devices as PICCO2 would allow tailoring of volume expansion necessary in hypoperfusion states to increase left ventricular volume and cardiac output. Studies in critically ill adults patients have demonstrated that passive leg raising autotransfusion and functional hemodynamic monitoring, by using pulse contour analysis, are reliable in the detection of fluid responsiveness. However, currently we have very few studies in pediatric patients using arterial pulse contour analysis and transpulmonary thermodilution, which does not allow the rational application of the hemodynamic variables for guiding fluid resuscitation.
This study pretend to assess 1) the value of dynamics and static indices of preload, and its combination with contractility and lung water indices, as predictors of fluid responsiveness in both spontaneously breathing and mechanically ventilated pediatric patients and 2) the value of stroke volume and pulse pressure changes during passive leg raising autotransfusion, as predictors of fluid responsiveness in pediatric patients.
In this observational study, the hemodynamical variables are registered during the hemodynamically unstable, stable and "normal" states of the pediatric patient and before and after clinically indicated fluid (crystalloid, colloid or hemoderivative) infusion. Passive leg raising hemodynamic changes will be compared with the hemodynamic changes caused by fluid infusion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- Pediatric patients admitted to PICU
- Patient equipped with a femoral arterial catheter and central venous catheter or who requires advanced hemodynamic monitoring
- Parents consent
Key exclusion criteria (9 listed)
- Absolute
- For passive leg raising procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
- Background: PubMed 19325359Brierley 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.
- Background: PubMed 18812805Michard 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.
- Background: PubMed 17080001Osman 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.
- Background: PubMed 1644961Lichtwarck-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.
- Background: PubMed 14605066Michard 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.
- Background: PubMed 18467896Teboul 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.
- Background: PubMed 18214429Monnet 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.
- Background: PubMed 16846530Heenen 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.
- Background: PubMed 18766112Kim 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.
- Background: PubMed 17762231Pinsky MR. Heart-lung interactions. Curr Opin Crit Care. 2007 Oct;13(5):528-31. doi: 10.1097/MCC.0b013e3282efad97.
- Background: PubMed 14743122Cecchetti 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.
- Background: PubMed 18431282Cecchetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro de la Oliva, MD PhD. study director
Hospital Universitario La Paz
Ignacio Sánchez-Díaz, MD PhD principal investigator
Hospital Universitario 12 de Octubre de Madrid
Elena Alvarez-Rojas, MD principal investigator
Hospital Universitario Ramón y Cajal de Madrid
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Sepsis, run by Hospital Universitario La Paz at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro de la Oliva, MD PhD (+34917277149, poliva.hulp@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157299, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010; AzTrials last refreshed its copy on 6 Nov 2026.