Clinical trial NCT05886192: The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
Official title: The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Septic Shock
Keywords: norepinephrine, vasopressin, organ perfusion.
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with septic shock with norepinephrine \>0.25ug/kg/min were enrolled. Informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group.

Contact the research assistant to obtain patient number information and print out the appropriate labels.Notify the ward dispensing nurse to open the experimental drug cassette (placed in the refrigerator 4℃ drug cabinet).

Extract the corresponding experimental medication according to the patient label number, dispense it and send it to the ward, label it and hand it over to the bedside nurse to start using it. The time point at which the medication was connected to the patient and activated was recorded as the zero point for the start of the study.

The data were monitored according to the time points specified in the study: baseline,0h , 6h, D1, D2, and post-drug withdrawal.


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

Primary outcomes:
measure: 28days-Mortality in ICU
timeFrame: 28 days
measure: ICU duration
timeFrame: an average of 1 year
Secondary outcomes:
measure: RVDEA/LVDEA
timeFrame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
measure: right ventricular thickness
timeFrame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
measure: Tricuspid Annular Plane Systolic Excursion
timeFrame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
measure: resistance index of superior mesenteric artery
timeFrame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
measure: venous excess ultrasound grading system(VexUS)
timeFrame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
measure: Intestinal ultrasound score
timeFrame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
measure: pulsatility index of the middle cerebral artery
timeFrame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: