BACKGROUND: A limited number of trials have investigated the efficacy of proton pump inhibitors for peptic ulcer bleeding, and some study design issues have been identified. AIM: To present the design of a large trial evaluating the effects of intravenous esomeprazole on clinical outcomes in high-risk patients who have undergone endoscopic haemostasis for peptic ulcer bleeding. METHODS: The Peptic Ulcer Bleed study is an international, randomized, double-blind, placebo-controlled trial comparing either esomeprazole 80 mg intravenous bolus infusion for 30 min followed by esomeprazole 8 mg/h intravenously for 71.5 h, or placebo infusion for 72 h, after successful endoscopic haemostasis in patients with peptic ulcer bleeding and associated high-risk stigmata. All patients will receive once daily oral esomeprazole 40 mg for 27 days after intravenous therapy. The primary end point is the rate of clinically significant re-bleeding during the first 72 h after endoscopy. Secondary end points include: rate of re-bleeding during the first 7 and 30 days after treatment; length of hospitalization; mortality; blood transfusion; endoscopic re-treatment and surgery. RESULTS: Expected 2008. CONCLUSIONS: The carefully designed protocol and quality control measures represent a pragmatic approach to contemporary challenges in peptic ulcer bleeding management and, it is hoped, qualify the Peptic Ulcer Bleed study as a new standard for future interventional studies.
RCT Entities:
BACKGROUND: A limited number of trials have investigated the efficacy of proton pump inhibitors for peptic ulcer bleeding, and some study design issues have been identified. AIM: To present the design of a large trial evaluating the effects of intravenous esomeprazole on clinical outcomes in high-risk patients who have undergone endoscopic haemostasis for peptic ulcer bleeding. METHODS: The Peptic Ulcer Bleed study is an international, randomized, double-blind, placebo-controlled trial comparing either esomeprazole 80 mg intravenous bolus infusion for 30 min followed by esomeprazole 8 mg/h intravenously for 71.5 h, or placebo infusion for 72 h, after successful endoscopic haemostasis in patients with peptic ulcer bleeding and associated high-risk stigmata. All patients will receive once daily oral esomeprazole 40 mg for 27 days after intravenous therapy. The primary end point is the rate of clinically significant re-bleeding during the first 72 h after endoscopy. Secondary end points include: rate of re-bleeding during the first 7 and 30 days after treatment; length of hospitalization; mortality; blood transfusion; endoscopic re-treatment and surgery. RESULTS: Expected 2008. CONCLUSIONS: The carefully designed protocol and quality control measures represent a pragmatic approach to contemporary challenges in peptic ulcer bleeding management and, it is hoped, qualify the Peptic Ulcer Bleed study as a new standard for future interventional studies.
Authors: Nl de Groot; Mgh van Oijen; K Kessels; M Hemmink; Blam Weusten; R Timmer; Wl Hazen; N van Lelyveld; Wl Curvers; Lc Baak; R Verburg; Jh Bosman; Lrh de Wijkerslooth; J de Rooij; Ng Venneman; M Pennings; K van Hee; Rch Scheffer; Rl van Eijk; R Meiland; Pd Siersema; Aj Bredenoord Journal: United European Gastroenterol J Date: 2014-06 Impact factor: 4.623
Authors: Dennis M Jensen; Gordon V Ohning; Thomas O G Kovacs; Kevin A Ghassemi; Rome Jutabha; Gareth S Dulai; Gustavo A Machicado Journal: Gastrointest Endosc Date: 2015-08-28 Impact factor: 9.427
Authors: Dennis M Jensen; Stefan Eklund; Tore Persson; Henrik Ahlbom; Robert Stuart; Alan N Barkun; Ernest J Kuipers; Joachim Mössner; James Y Lau; Joseph J Sung; Jan Kilhamn; Tore Lind Journal: Am J Gastroenterol Date: 2017-01-17 Impact factor: 10.864
Authors: Aravamuthan Sreedharan; Janet Martin; Grigorios I Leontiadis; Stephanie Dorward; Colin W Howden; David Forman; Paul Moayyedi Journal: Cochrane Database Syst Rev Date: 2010-07-07