The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: norepinephrine+vasopressin norepinephrine+vasopressin |
Drug: norepinephrine+vasopressin
Norepinephrine combined with vasopressin to maintain blood pressure
|
| Placebo Comparator: Norepinephrine norepinephrine |
Drug: Norepinephrine
norepinephrine
|
Outcome Measures
Primary Outcome Measures
- 28days-Mortality in ICU [28 days]
28 day mortality rate
- ICU duration [an average of 1 year]
Residence time in ICU
Secondary Outcome Measures
- RVDEA/LVDEA [baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)]
bedside cardiac ultrasound parameters,Qualitative indicators: RVDEA/LVDEA
- right ventricular thickness [baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)]
bedside cardiac ultrasound parameters qualitative indicators: right ventricular thickness,
- Tricuspid Annular Plane Systolic Excursion [baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)]
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'.
- resistance index of superior mesenteric artery [baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)]
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
- venous excess ultrasound grading system(VexUS) [baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)]
Liver vein, portal vein, and renal vein.
- Intestinal ultrasound score [baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)]
Intestinal ultrasound score :Including the diameter of the small intestine, the thickness of the small intestine wall, and the frequency of small intestine peristalsis
- pulsatility index of the middle cerebral artery [baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)]
Cranial ultrasound measurement indexes Cranial ultrasound measurement indexes: pulsatility index of the middle cerebral artery
Eligibility Criteria
Criteria
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
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Patient is on posterior pituitary hormone
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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
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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
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malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50%
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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.
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Likely death expected within 12 hours
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Family or physician plans to implement a palliative care plan for the patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-PUMCH-B-115