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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| norepinephrine+vasopressin | Experimental | norepinephrine+vasopressin |
|
| Norepinephrine | Placebo Comparator | norepinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| norepinephrine+vasopressin | Drug | Norepinephrine combined with vasopressin to maintain blood pressure |
|
| 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 |
| 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, |
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Inclusion Criteria:
Septic shock patients with norepinephrine>0.25ug/kg/min
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou Yuankai, MD | Contact | 69152300 | zhouyuankai@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Norepinephrine | Drug | norepinephrine |
|
| 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) |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C041373 | lidocaine, norepinephrine, vasopressin drug combination |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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