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

Phase 4

Recruiting

• Conditions: Septic Shock
• Interventions: Drug: norepinephrine+vasopressin; Drug: Norepinephrine

• Registration Number: NCT05886192
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-01
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02
• Primary Completion: 2025-01-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Septic shock patients with norepinephrine>0.25ug/kg/min

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
norepinephrine+vasopressin	norepinephrine+vasopressin	norepinephrine+vasopressin
Norepinephrine	Norepinephrine	norepinephrine

Primary Outcome Measures

Name	Time	Method
28days-Mortality in ICU	28 days	28 day mortality rate
ICU duration	an average of 1 year	Residence time in ICU

Secondary Outcome Measures

Name	Time	Method
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'.
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
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China