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Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure

Primary Purpose

Sepsis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Recombinant human brain natriuretic peptide
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, Heart Failure, AKI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • sepsis complicated with heart failure（Diagnosed by sepsis 3.0）
  • Heart failure: BNP rises by 600 pg/ml
  • Age>=18 years old

Exclusion Criteria:

  • Hemodynamically unstable
  • Pregnant
  • Disagree with comprehensive and active life support treatment
  • coronary heart disease, myocardial infarction, and cardiac insufficiency
  • chronic renal insufficiency

Sites / Locations

  • Ju Minjie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

rhBNP in the treatment of sepsis complicated with heart failure

Conventional treatment group

Arm Description

Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure

Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure

Outcomes

Primary Outcome Measures

the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function
The decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)
PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group
The improvement degree of cardiac index in recombinant human brain natriuretic peptide group

Secondary Outcome Measures

ICU mortality and hospital mortality
Comparison between rhBNP group and control group
Mechanical ventilation time after entering ICU
Comparison between rhBNP group and control group

Full Information

First Posted
September 30, 2021
Last Updated
October 28, 2021
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05111769
Brief Title
Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure
Official Title
Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan 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
No

5. Study Description

Brief Summary
The investigators intend to conduct clinical studies to determine the efficacy of rhBNP in the treatment of septic related dysfunction and kidney dysfunction
Detailed Description
Sepsis is one of the common critical diseases in ICU with high mortality. Septic shock patients are often accompanied by multiple organ dysfunction (MODS), of which more than 50% of patients with varying degrees of myocardial injury.The investigators hope to find a drug with a protective effect on cardiac function and kidney function, so as to treat sepsis more effectively in the treatment of sepsis. Recombinant human brain natriuretic peptide (rhBNP) was approved by FDA in 2001 for the treatment of acute decompensated heart failure.These effects play a role in the protection of cardiac and kidney function, and have achieved good results in patients with cardiac insufficiency and AKI caused by cardiac surgery. The investigators are going to carry out related research from the following aspects: 1. To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis, Heart Failure, AKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rhBNP in the treatment of sepsis complicated with heart failure
Arm Type
Experimental
Arm Description
Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure
Arm Title
Conventional treatment group
Arm Type
No Intervention
Arm Description
Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure
Intervention Type
Drug
Intervention Name(s)
Recombinant human brain natriuretic peptide
Intervention Description
1. To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time.
Primary Outcome Measure Information:
Title
the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function
Description
The decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)
Time Frame
72 hours after rhBNP
Title
PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group
Description
The improvement degree of cardiac index in recombinant human brain natriuretic peptide group
Time Frame
72 hours after recombinant human brain natriuretic peptide
Secondary Outcome Measure Information:
Title
ICU mortality and hospital mortality
Description
Comparison between rhBNP group and control group
Time Frame
One month after entering ICU
Title
Mechanical ventilation time after entering ICU
Description
Comparison between rhBNP group and control group
Time Frame
72 hours after recombinant human brain natriuretic peptide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: sepsis complicated with heart failure（Diagnosed by sepsis 3.0） Heart failure: BNP rises by 600 pg/ml Age>=18 years old Exclusion Criteria: Hemodynamically unstable Pregnant Disagree with comprehensive and active life support treatment coronary heart disease, myocardial infarction, and cardiac insufficiency chronic renal insufficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minjie Ju, PHD
Phone
8613817014079
Email
ju.minjie@zs-hospital.sh.cn
Facility Information:
Facility Name
Ju Minjie
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure

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