Measuring blood flow and circulation in ICU patients with septic shock
Effects of Norepinephrine on Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU Patients with Septic Shock
This study is testing how the medication norepinephrine affects blood flow in adults with septic shock to help doctors provide better treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Hvidovre, Copenhagen) |
| Trial ID | NCT05225402 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the effects of norepinephrine on macro- and microcirculation in adult patients experiencing septic shock. By evaluating hemodynamic measurements during norepinephrine titration and fluid resuscitation, the study seeks to identify discrepancies between macro- and microcirculatory parameters. The findings will enhance understanding of individualized treatment strategies for septic shock, focusing on optimizing fluid and norepinephrine administration. This multicenter approach involves multiple hospitals to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates include adults with suspected or documented infections requiring vasopressors to maintain adequate blood pressure and elevated serum lactate levels.
Not a fit: Patients with severe valvular pathology, cardiac arrhythmias, or those on lithium or other vasopressors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with septic shock.
How similar studies have performed: While the effects of norepinephrine on macro- and microcirculation have been studied, this specific approach in the context of septic shock is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspected or documented infection * Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg * Serum lactate levels \>2 mmol/L * Norepinephrine infusion of \> 0.2 mcg/kg/min Exclusion Criteria: * Absolute contraindication for esophageal doppler or urinary catheter insertion as noted in the patients' charts. * Severe valvular pathology and cardiac arrhythmias resulting in severe hemodynamic instability. * Lithium treatment * Treatment with other vasopressor or inotropic drugs.
Where this trial is running
Hvidovre, Copenhagen
- Hvidovre Hospital — Hvidovre, Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Henrik Wolsted, MD
- Email: Henrik.wolsted.01@regionh.dk
- Phone: +45 21 49 44 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.