search
Back to results

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

Primary Purpose

Septic Shock

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
norepinephrine+vasopressin
Norepinephrine
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring norepinephrine, vasopressin, organ perfusion.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Septic shock patients with norepinephrine>0.25ug/kg/min Exclusion Criteria: 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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

norepinephrine+vasopressin

Norepinephrine

Arm Description

norepinephrine+vasopressin

norepinephrine

Outcomes

Primary Outcome Measures

28days-Mortality in ICU
28 day mortality rate
ICU duration
Residence time in ICU

Secondary Outcome Measures

RVDEA/LVDEA
bedside cardiac ultrasound parameters,Qualitative indicators: RVDEA/LVDEA
right ventricular thickness
bedside cardiac ultrasound parameters qualitative indicators: right ventricular thickness,
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'.
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
venous excess ultrasound grading system(VexUS)
Liver vein, portal vein, and renal vein.
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
pulsatility index of the middle cerebral artery
Cranial ultrasound measurement indexes Cranial ultrasound measurement indexes: pulsatility index of the middle cerebral artery

Full Information

First Posted
May 5, 2023
Last Updated
May 23, 2023
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05886192
Brief Title
The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
Official Title
The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
norepinephrine, vasopressin, organ perfusion.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
norepinephrine+vasopressin
Arm Type
Experimental
Arm Description
norepinephrine+vasopressin
Arm Title
Norepinephrine
Arm Type
Placebo Comparator
Arm Description
norepinephrine
Intervention Type
Drug
Intervention Name(s)
norepinephrine+vasopressin
Intervention Description
Norepinephrine combined with vasopressin to maintain blood pressure
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
norepinephrine
Primary Outcome Measure Information:
Title
28days-Mortality in ICU
Description
28 day mortality rate
Time Frame
28 days
Title
ICU duration
Description
Residence time in ICU
Time Frame
an average of 1 year
Secondary Outcome Measure Information:
Title
RVDEA/LVDEA
Description
bedside cardiac ultrasound parameters,Qualitative indicators: RVDEA/LVDEA
Time Frame
baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Title
right ventricular thickness
Description
bedside cardiac ultrasound parameters qualitative indicators: right ventricular thickness,
Time Frame
baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Title
Tricuspid Annular Plane Systolic Excursion
Description
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'.
Time Frame
baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Title
resistance index of superior mesenteric artery
Description
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
Time Frame
baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Title
venous excess ultrasound grading system(VexUS)
Description
Liver vein, portal vein, and renal vein.
Time Frame
baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Title
Intestinal ultrasound score
Description
Intestinal ultrasound score :Including the diameter of the small intestine, the thickness of the small intestine wall, and the frequency of small intestine peristalsis
Time Frame
baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Title
pulsatility index of the middle cerebral artery
Description
Cranial ultrasound measurement indexes Cranial ultrasound measurement indexes: pulsatility index of the middle cerebral artery
Time Frame
baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Septic shock patients with norepinephrine>0.25ug/kg/min Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Yuankai, MD
Phone
69152300
Email
zhouyuankai@aliyun.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
010-69152300

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs