Early TIPS in Real Life for Patient Admitted to Intensive Care Unit

Does Early TIPS Improve Survival for Cirrhotic Patients With Acute Esophageal Variceal Bleeding Admitted in Intensive Care Unit?

Patrocinadores

Patrocinador principal: Nantes University Hospital

Colaborador: Departmental Hospital Vendee

Fuente Nantes University Hospital
Resumen breve

Acute esophageal variceal bleeding (AEVB) is a serious complication of cirrhosis, with high morbidity and mortality. The latest European recommendations(1) recommend the early implementation, within 72 hours following esophageal variceal bleeding, of a transhepatic porto-systemic shunt set up by transjugular route (TIPS) called "early TIPS" in patients at high risk of recurrence, i.e. Child C<14 or Child B with active bleeding at the time of endoscopy. The implementation of early TIPS appears to improve survival without transplantation in these patients, although the benefit among Child B patients without active bleeding has yet to be demonstrated.

Renal failure is a determining factor in the prognosis of the cirrhotic patient. For patients with refractory ascites, or type 2 hepato-renal syndrome (i.e. chronic renal failure related to portal hypertension), the use of TIPS is recommended. Although a few studies with low levels of evidence have reported a benefit in the placement of TIPS in hepato-renal syndrome type 1 (i.e. acute renal failure related to portal hypertension), the European recommendations do not recommend the use of TIPS in this context due to lack of studies on the subject. Some studies have shown an improvement in renal function after performing TIPS in refractory ascites. To date, no studies have evaluated the impact of the implementation of early-TIPS on renal function in intensive care patients.

The investigators would like to evaluate the impact on survival without liver transplantation on D28 of the implementation of early-TIPS in cirrhotic patients with AEVB requiring ICU hospitalization, compared to standard treatment (medical and endoscopic).

Descripción detallada

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of cirrhosis admitted to ICUs at the Nantes University Hospital, and departmental Hospital of Vendée from January 1, 2012, to december 31, 2018. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to the type of treatment performed: early TIPS or standard treatment.

Estado general Not yet recruiting
Fecha de inicio December 1, 2019
Fecha de Terminación March 1, 2020
Fecha de finalización primaria January 1, 2020
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
survival without liver transplantation day 28
Resultado secundario
Medida Periodo de tiempo
day 90 mortality Comparison of day 90 mortality between the two groups.
Inscripción 100
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: early tips

Descripción: patients with early tips

Etiqueta de grupo de brazo: Early Tips

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

Inclusion Criteria:

Adult patients (age >18 years) with cirrhosis Admitted in Intensive Care Unit Cirrhosis Child B or Child C With Acute esophageal variceal bleeding confirmed by endoscopy.

Exclusion Criteria:

Patients under guardianship Patients with a decision to limit care at the admission Patients with already a TIPS. Patients with a invasive multifocal hepatocellular carcinoma pregnancy

Género: Female

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Contacto general

Apellido: Garret Charlotte, MD

Teléfono: 0240084737

Email: [email protected]

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Early Tips

Descripción: Patients wtih early tips for Acute esophageal variceal bleeding

Etiqueta: stantard treatment

Descripción: patients with standard treatment (medical + endoscopic) for Acute esophageal variceal bleeding

Acrónimo REALYTIPS
Datos del paciente No
Información de diseño del estudio

Modelo de observación: Case-Control

Perspectiva de tiempo: Retrospective

Fuente: ClinicalTrials.gov