Shock, Septic Clinical Trial
Official title:
Simultaneous Administration of Norepinephrine, Angiotensin II, and Vasopressin in Septic Shock Patients
The goal of this prospective randomized controlled trial is to compare the effects of classic stepwise vs. early balanced multimodal vasopressor strategies in septic shock.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | November 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (= 18 years) - Sepsis (an acute change in total SOFA score =2 points consequent to infection) with persisting hypotension requiring vasopressors to maintain MAP = 65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation - Patients must have a Cardiac Index (CI) >2.3 L/min/m2 (measured by bedside echocardiography, PiCCO catheter, or Swan-Ganz catheter) Exclusion Criteria: - Death expected < 24 hours - Pregnancy (suspected or confirmed) - Surgery is expected for the source of the infection - Inter-hospital transfer is expected during the first 72 hours of hospitalization - Liver failure with a Model for End-Stage Liver Disease (MELD) score of = 30 (3 months observed mortality at 52.6 %) - Patients on VA-ECMO - Known allergy to mannitol - Patients with systemic sclerosis or Raynaud syndrome |
Country | Name | City | State |
---|---|---|---|
Slovenia | Medical intensive care unit UMC Maribor | Maribor |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Maribor |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Survival to ICU discharge | From date of ICU admission until date of ICU discharge or death during ICU stay whichever came first, assessed up to 8 weeks | ||
Other | 28-day mortality | 28 days after first admission to the ICU | ||
Primary | Rate of change in renin levels | There is an increasing amount of data that renin is the best marker of tissue hypoperfusion and predictor of ICU mortality in patients with sepsis and septic shock, even outperforming lactate. Renin increased between the first and third day in non-survivors, but dropped in survivors. The rate of change in renin concentration but not lactate concentration in ICU patients over first 72 hours is associated with in hospital mortality. | 72 hours | |
Secondary | Compare lactate levels | In critically ill patients, plasma lactate is commonly used to guide hemodynamic resuscitation. Hyperlactatemia has been widely recognized as a marker of tissue hypoxia/hypoperfusion but it can also result from increased or accelerated aerobic glycolysis during the stress response and may represent an important energy source in critically ill patients. Resuscitation to normalize lactate levels could worsen physiological status. | 72 hours | |
Secondary | Compare ? Sequential Organ Failure Assessment (SOFA) score | The purpose is to monitor the rate of organ dysfunction. Score ranges from 0 (best) to 24 (worst) points. | 72 hours | |
Secondary | Compare acute kidney injury rate | The purpose is to monitor acute kidney injury based on Improving Global Outcomes (KDIGO) definition and staging system. | 72 hours |
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