Therapeutic system for managing septic shock patients

The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients

This study is testing if adding vasopressin to norepinephrine can help patients with septic shock feel better and improve their organ function.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05886192 on ClinicalTrials.gov

What this trial studies

This study focuses on patients suffering from septic shock who are receiving norepinephrine at doses greater than 0.25ug/kg/min. Participants will be randomly assigned to receive either a combination of norepinephrine and vasopressin or norepinephrine alone. The study will monitor various data points at specified intervals to assess the effectiveness of the treatment. The goal is to improve organ perfusion and overall patient outcomes in those experiencing septic shock.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with septic shock requiring norepinephrine treatment.

Not a fit: Patients under 18 years of age or those with acute coronary syndrome or severe liver failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with septic shock by improving organ perfusion.

How similar studies have performed: Other studies have explored similar combinations of vasopressors, showing potential benefits, but this specific approach may be novel.

Eligibility criteria

Inclusion Criteria:

Septic shock patients with norepinephrine\>0.25ug/kg/min

Exclusion Criteria:

1. Under 18 years of age
2. Acute coronary syndrome requiring treatment
3. have been treated with VA-ECMO
4. VV-ECMO treatment has been administered for less than 12 hours
5. Patient is on posterior pituitary hormone
6. Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 30
7. Patients requiring more than 500 mg of hydrocortisone or equivalent glucocorticoid daily as a fixed dose
8. absolute neutrophil counts below 1,000/mm3
9. Patients with active bleeding who are expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate patients with active bleeding that is expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate
10. malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50%
11. Confirmed or suspected acute mesenteric ischemia. If the investigator believes that the patient's condition is highly suspicious but not confirmed by conventional criteria The investigator may exclude a patient if, in the opinion of the investigator, the patient's condition is highly suspicious but not confirmed by conventional criteria, or if the treating physician has initiated empiric therapy.
12. Likely death expected within 12 hours
13. Family or physician plans to implement a palliative care plan for the patient

Where this trial is running

Beijing, Beijing

• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zhou Yuankai, MD

Conditions Septic Shock; norepinephrine, vasopressin, organ perfusion.