E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
FLUID THERAPY IN ACUTE PANCREATITIS |
FLUIDOTERAPIA INICIAL EN LA PANCREATITIS AGUDA |
|
E.1.1.1 | Medical condition in easily understood language |
FLUID THERAPY IN ACUTE PANCREATITIS |
FLUIDOTERAPIA INICIAL EN LA PANCREATITIS AGUDA |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033647 |
E.1.2 | Term | Pancreatitis acute |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess the incidence of systemic inflammatory response syndrome and the degree of elevation of CRP at 48-72 hours in patients with acute pancreatitis treated with saline versus Ringer's lactate during the first 72 hours of hospitalization |
Valorar la incidencia de síndrome de respuesta inflamatoria sistémica y el grado de elevación de PCR a las 48-72 horas en pacientes con pancreatitis aguda tratados con suero fisiólogico frente a Ringer Lactato durante las primeras 72 horas de hospitalización. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the incidence of local complications (pancreatic necrosis, acute and collections) To evaluate the incidence of organ failure Rate of hospital stay Assess need for ICU admission |
Valorar la incidencia de complicaciones locales (colecciones agudas y necrosis pancreática) Valorar la incidencia de fallo orgánico Valorar la estancia hospitalaria Valorar necesidad de ingreso en UCI |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients over 18 years Patients with first episode of acute pancreatitis Patients that accept to participate in the trial signing the informed consent |
Pacientes mayores de 18 años Pacientes con primer episodio de pancreatitis aguda Aceptación libre de participar en el ensayo, con consentimiento informado por escrito del paciente |
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E.4 | Principal exclusion criteria |
-History of severe renal disease -Heart failure NYHA functional class> II -COPD with home oxygen -Suspected or confirmed active infection -Sodium Deric Hypernatremia > 1 mEq / L or hyponatremia (<135 mEq / L) -Rhabdomyolysis -Onset of pain more than 24 hours - Metastatic neoplasia - Active inflammatory bowel disease - Autoimmune disease - Active chronic infection (AIDS, tuberculosis) |
-Historia de enfermedad grave renal -Insuficiencia cardíaca de clase funcional NYHA > II -EPOC con oxigeno domiciliario -Infeccion activa sospechada o confirmada -Hipernatremia sodio dérico > 1 mEq/L o hiponatremia (<135 mEq/L) -Rabdomiolisis -Inicio de síntomas de dolor más de 24 horas -Neoplasi metastásica -Enfermedad inflamatoria intestinal activa -Enfermedad autoinmune -Infección crónica activa (VIH, tuberculosis) |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Compliance criteria for systemic inflammatory response syndrome (SIRS) from the 24 hours of admission -SIRS criteria compliance date. -Days until SIRS criteria compliance - C-reactive protein in blood at 48 and 72 hours |
-Cumplimiento de criterios de síndrome de respuesta inflamatoria sistémica (SRIS) a partir de las 24 horas de ingreso -Fecha de cumplimiento criterios SRIS. -Duración en días de cumplimiento de criterios SRIS -Proteina C reactiva en sangre a las 48 y 72 horas |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24,48, 72 hours 7 days hospital discharged |
24,48, 72 horas 7 días Alta hospitalaria |
|
E.5.2 | Secondary end point(s) |
-Severity of acute pancreatitis -Development of pancreatic necrosis, acute collections and organ failure -Hospital stay in days -Need for ICU admission and duration |
-Gravedad de pancreatitis aguda -Desarrollo de necrosis pancreática, colecciones agudas y fallo orgánico -Estancia hospitalaria en días -Necesidad de ingreso en UCI y duración |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At hospital discharge |
Al alta hospitalaria |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
-The patient has completed the study -The patient wants to leave (abandon) -The doctor will decide for safety reasons |
-El paciente ha completado el estudio -El paciente desea retirarse (abandono) -El médico lo decide por motivos de seguridad |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |