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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Drug: norepinephrine+vasopressin; Drug: Norepinephrine

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhou Yuankai, MD; Phone Number: 69152300; Email: zhouyuankai@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Phone Number: 010-69152300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: norepinephrine+vasopressin	Drug: norepinephrine+vasopressin; Norepinephrine combined with vasopressin to maintain blood pressure
Placebo Comparator: Norepinephrine; norepinephrine	Drug: Norepinephrine; norepinephrine

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Estimated): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: norepinephrine, vasopressin, organ perfusion.
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Hemostatics; Coagulants; Sympathomimetics; Vasoconstrictor Agents; Antidiuretic Agents; Norepinephrine; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: 2022-PUMCH-B-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No