ABSTRACT
BACKGROUND: Goal directed therapy (GDT) is able to improve mortality and reduce complications in selected high-risk patients undergoing major surgery. The aim of this study is to compare two different strategies of perioperative hemodynamic optimization: one based on optimization of preload using dynamic parameters of fluid-responsiveness and the other one based on estimated oxygen extraction rate (O2ER) as target of hemodynamic manipulation. METHODS: This is a multicenter randomized controlled trial. Adult patients undergoing elective major open abdominal surgery will be allocated to receive a protocol based on dynamic parameters of fluid-responsiveness or a protocol based on estimated O2ER. The hemodynamic optimization will be continued for 6 h postoperatively. The primary outcome is difference in overall postoperative complications rate between the two protocol groups. Fluids administered, fluid balance, utilization of vasoactive drugs, hospital length of stay and mortality at 28 day will also be assessed. DISCUSSION: As a predefined target of cardiac output (CO) or oxygen delivery (DO2) seems to be not adequate for every patient, a personalized therapy is likely more appropriate. Following this concept, dynamic parameters of fluid-responsiveness allow to titrate fluid administration aiming CO increase but avoiding fluid overload. This approach has the advantage of personalized fluid therapy, but it does not consider if CO is adequate or not. A protocol based on O2ER considers this second important aspect. Although positive effects of perioperative GDT have been clearly demonstrated, currently studies comparing different strategies of hemodynamic optimization are lacking. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04053595. Registered on 12/08/2019.
Subject(s)
Abdomen/surgery , Elective Surgical Procedures/methods , Fluid Therapy/methods , Oxygen/metabolism , Adult , Cardiac Output/physiology , Hemodynamics/physiology , Humans , Perioperative Care/methods , Postoperative Complications/epidemiologyABSTRACT
The article proposes a critical reflection on issues that appeal to the conscience clause as part of end of life care can produce and what can guarantee freedom of conscience, self-determination of those involved and respect for the dignity of the sick person. After a philosophical and normative analysis, the article is organized on the basis of two important documents for discussion: a position paper of Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI) signed by several scientific societies "Grandi insufficienze d'organo end stage: cure intensive o cure palliative?" and the Design of Law currently being debated "Norme in materia di consenso informato e di disposizioni anticipate di trattamento". In particular, the conscience clause has been discussed in the light of advance care planning (ACP), which represents the instrument to guarantee the shared planning of care and the shared-decision making. In this context, recourse to the clause of conscience brings out critical ethical and deontological issues that the article discusses, using the position paper SIAARTI and the text of law currently being debated, both built on the assumptions of a shared care relationship, where patient has a key-role in medical decisions.
