NCT04173299

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?

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Esophageal Varicose Veins

Interventions

Type	Name	Description
PROCEDURE	early tips	patients with early tips

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-01-01
• Completion: 2020-03-01
• First posted: 2019-11-21
• Last updated: 2019-11-21