Clinical trial NCT05111769: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Keywords: sepsis
Heart Failure
AKI
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function
timeFrame: 72 hours after rhBNP
measure: PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group
timeFrame: 72 hours after recombinant human brain natriuretic peptide
Secondary outcomes:
measure: ICU mortality and hospital mortality
timeFrame: One month after entering ICU
measure: Mechanical ventilation time after entering ICU
timeFrame: 72 hours after recombinant human brain natriuretic peptide
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ju Minjie
state: Shanghai
Study officials:
References: