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

Study Overview
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Brief Summary
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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.

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

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: norepinephrine+vasopressin
* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septic shock patients with norepinephrine>0.25ug/kg/min Exclusion Criteria: Under 18 years of age Acute coronary syndrome requiring treatment have been treated with VA-ECMO VV-ECMO treatment has been administered for less than 12 hours Patient is on posterior pituitary hormone Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 30 Patients requiring more than 500 mg of hydrocortisone or equivalent glucocorticoid daily as a fixed dose absolute neutrophil counts below 1,000/mm3 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 malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50% 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. Likely death expected within 12 hours Family or physician plans to implement a palliative care plan for the patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: norepinephrine+vasopressin<br>norepinephrine+vasopressin | Drug: norepinephrine+vasopressin<br>* Norepinephrine combined with vasopressin to maintain blood pressure<br>|
| Placebo Comparator: Norepinephrine<br>norepinephrine | Drug: Norepinephrine<br>* norepinephrine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28days-Mortality in ICU | 28 day mortality rate | 28 days | 
| ICU duration | Residence time in ICU | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RVDEA/LVDEA | bedside cardiac ultrasound parameters,Qualitative indicators: RVDEA/LVDEA | baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week) | 
| right ventricular thickness | bedside cardiac ultrasound parameters qualitative indicators: right ventricular thickness, | baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week) | 
| Tricuspid Annular Plane Systolic Excursion | Right ventricular systolic function indicators: Tricuspid,Annular,Plane,Systolic,Excursion (TAPSE) Right ventricular pressure indicators: TV max, peak pulmonary artery regurgitation Other cardiac parameters: E/A, E/E'. | baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week) | 
| resistance index of superior mesenteric artery | Blood flow parameters of superior mesenteric artery: resistance index 2) VexUS: Liver vein, portal vein, and renal vein. 3) Arterial pressure monitoring waveform. 4) Intestinal ultrasound score | baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week) | 
| venous excess ultrasound grading system(VexUS) | Liver vein, portal vein, and renal vein. | baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week) | 
| Intestinal ultrasound score | Intestinal ultrasound score :Including the diameter of the small intestine, the thickness of the small intestine wall, and the frequency of small intestine peristalsis | baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week) | 
| pulsatility index of the middle cerebral artery | Cranial ultrasound measurement indexes Cranial ultrasound measurement indexes: pulsatility index of the middle cerebral artery | baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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norepinephrine, vasopressin, organ perfusion.