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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886192
• Other study ID #: 2022-PUMCH-B-115
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: Peking Union Medical College Hospital
• Contact: Zhou Yuankai, MD
• Phone: 69152300
• Email: zhouyuankai[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock

Intervention

Drug:
• norepinephrine+vasopressin
Norepinephrine combined with vasopressin to maintain blood pressure
• Norepinephrine
norepinephrine

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28days-Mortality in ICU	28 day mortality rate	28 days
Primary	ICU duration	Residence time in ICU	an average of 1 year
Secondary	RVDEA/LVDEA	bedside cardiac ultrasound parameters,Qualitative indicators: RVDEA/LVDEA	baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Secondary	right ventricular thickness	bedside cardiac ultrasound parameters qualitative indicators: right ventricular thickness,	baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Secondary	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)
Secondary	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)
Secondary	venous excess ultrasound grading system(VexUS)	Liver vein, portal vein, and renal vein.	baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Secondary	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)
Secondary	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)