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1.
Trials ; 25(1): 288, 2024 Apr 29.
Article in English | MEDLINE | ID: mdl-38685032

ABSTRACT

BACKGROUND: Acute kidney injury (AKI) is a significant postoperative complication associated with increased mortality and hospital costs. Hemodynamic strategies, such as goal-directed therapy, might reduce AKI risk. Predicting and proactively managing intraoperative hypotension may be helpful. This trial aims to investigate if a preemptive hemodynamic strategy guided by the hypotension prediction index (HPI) can decrease the incidence of moderate-to-severe AKI within 30 days following major elective abdominal surgery. METHODS: This is an open-label, controlled, multicenter, randomized clinical trial that involves daily patient follow-up until hospital discharge. Inclusion criteria are patients aged over 65 and/or categorized as ASA III or IV physical status, undergoing major elective abdominal surgery (general, urological, or gynecological procedures) via laparoscopic or open approach under general or combined anesthesia. INTERVENTION: In the intervention group, hemodynamic management will be based on the HPI and the advanced functional hemodynamic variables provided by the Hemosphere platform and the AcumenIQ® sensor (Edwards Lifesciences). The primary outcome is the incidence of moderate-to-severe AKI within 7 days post-surgery. Secondary outcomes include postoperative complications and 30-day mortality. DISCUSSION: This study explores the potential of HPI-guided hemodynamic management in reducing AKI after major elective abdominal surgery, with implications for postoperative outcomes and patient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05569265. Registered on October 6, 2022.


Subject(s)
Abdomen , Acute Kidney Injury , Hypotension , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Humans , Acute Kidney Injury/prevention & control , Acute Kidney Injury/etiology , Acute Kidney Injury/therapy , Acute Kidney Injury/diagnosis , Abdomen/surgery , Hypotension/prevention & control , Hypotension/etiology , Elective Surgical Procedures , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Treatment Outcome , Female , Aged , Time Factors , Hemodynamics , Male , Early Goal-Directed Therapy , Risk Factors
2.
Minerva Anestesiol ; 82(5): 582-98, 2016 May.
Article in English | MEDLINE | ID: mdl-26198765

ABSTRACT

INTRODUCTION: The risks and benefits of transfusing critically ill patients continue to evoke controversy. Specifically, the critically ill patients with active ischemic cardiac disease continue to represent a "gray area" in the literature. EVIDENCE ACQUISITION: Meta-analysis of the effects of lower versus higher hemoglobin thresholds on mortality in critically ill patients was carried out using PRISMA methodology. A systematic research was performed in PubMed, Embase, and the Cochrane Library (last update, December 2014). INCLUSION CRITERIA: Anemic critically ill adult patients admitted to intensive care units and/or anemic patients with acute coronary syndrome in which a restrictive vs. liberal transfusion therapy was compared. PRIMARY ENDPOINT: mortality. Included studies were subjected to quantifiable analysis, predefined subgroup analysis, trial sequential analysis and predefined sensitivity analysis. EVIDENCE SYNTHESIS: Thirty RCT's were initially identified; 6 fulfilled the inclusion criteria, including 2156. There were no differences in mortality between the restrictive and liberal groups (RR: 0.86, 95% CI 0.70-1.05 P=0.14), neither in patients with chronic cardiovascular disease subgroup (RR: 1.13, 95% IC 0.88-1.46 P=0.34). However, there is a trend towards decreased mortality in the subgroup critically ill (RR: 0.86, 95% CI 0.73-1.01 P=0.06); while in the subgroup of patients with acute myocardial infarct seems like it might be a non-significant trend towards increased mortality (RR: 3.85, 95% CI 0.82-18.0 P=0.09). CONCLUSIONS: Restrictive strategy is at least as effective to liberal strategy in critically ill patients. Nevertheless, there is insufficient evidence to recommend a restrictive strategy for patients with acute coronary syndrome.


Subject(s)
Acute Coronary Syndrome/therapy , Anemia/therapy , Critical Illness , Erythrocyte Transfusion , Hemoglobins , Acute Coronary Syndrome/mortality , Anemia/mortality , Erythrocyte Transfusion/mortality , Humans , Randomized Controlled Trials as Topic
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