PhD Scientific Days 2024

Budapest, 9-10 July 2024

Poster Session S - Health Sciences 2.

Early resuscitation with vasopressor and fluid versus fluid resuscitation alone in hemodynamically unstable patients with acute gastrointestinal bleeding – study protocol for a randomized controlled feasibility trial


Edina Tari1, Brigitta Teutsch1, Bánk Fenyves2, Szabolcs Gaál2, Judit Imecz2, Péter Hegyi1, Csaba Varga2, Bálint Erőss1
1: Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
2: Deparment of Emergency Medicine, Semmelweis University, Budapest, Hungary

Text of the abstract

Acute gastrointestinal bleeding (GIB) is a potentially life-threatening event requiring emergency medical care. Around 20-30% of patients with acute GIB will develop hemodynamic instability (HI), associated with high mortality and rebleeding rates. However, the recommendations in the current guidelines regarding the optimal resuscitation of these patients are insufficient.
We aim to compare the efficacy and safety of combined vasopressor and fluid therapy in the resuscitation of patients developing HI after an acute GIB episode compared to standard fluid resuscitation.
A feasibility study will be conducted with an adaptive trial design for a prospective, multicentre, open-label, two-armed RCT with a superiority study design.
10-10 participants will be randomly assigned both to group A ("combined resuscitation with fluid and vasopressor") and group B (standard fluid resuscitation) in a 1:1 ratio. The trial's primary outcome will be the time to reach the state of hemodynamic stability, defined by NEWS2 score <3 AND decreasing lactate AND/OR increasing BE levels, compared to baseline. The secondary outcomes will include the volume of administered fluid (ml) to reach the primary endpoint and the rate of reaching the state of hemodynamic stability in both arms, for example.
We hypothesize that patients receiving early vasopressor therapy will reach the state of hemodynamic stability earlier and require a lower total volume of infused crystalloids.