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

NCT05886192 | Unknown Phase 4 DMC

• 1 other identifier: 2022-PUMCH-B-115
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

norepinephrine, vasopressin, organ perfusion.

Outcome Measures

Primary Outcomes (2)

• 28days-Mortality in ICU

  28 day mortality rate

  28 days

• ICU duration

  Residence time in ICU

  an average of 1 year

Secondary Outcomes (7)

• RVDEA/LVDEA

  baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)

• right ventricular thickness

  baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)

• Tricuspid Annular Plane Systolic Excursion

  baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)

• resistance index of superior mesenteric artery

  baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)

• venous excess ultrasound grading system(VexUS)

  baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)

Study Arms (2)

norepinephrine+vasopressin

EXPERIMENTAL

norepinephrine+vasopressin

Drug: norepinephrine+vasopressin

Norepinephrine

PLACEBO COMPARATOR

norepinephrine

Drug: Norepinephrine

Interventions

norepinephrine+vasopressin DRUG

Norepinephrine combined with vasopressin to maintain blood pressure

norepinephrine+vasopressin

Norepinephrine DRUG

norepinephrine

Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Patient is on posterior pituitary hormone
• 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
• 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
• malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50%
• 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.
• Likely death expected within 12 hours
• Family or physician plans to implement a palliative care plan for the patient

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Diabetes Insipidus

Interventions

lidocaine, norepinephrine, vasopressin drug combination; Norepinephrine

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Zhou Yuankai, MD

CONTACT

69152300; zhouyuankai@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 2, 2023
• Study Start: May 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: September 30, 2025
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)