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To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was administered as a continuous infusion for 24 hours , pulmonary artery pressure and other hemodynamic parameters were monitored by Swan- Ganz catheter.
Pulmonary hypertension (PH) is a descriptive name for abnormally elevated pressures in the pulmonary vasculature, which seriously affects the quality of life and survival of patients. Currently, no effective drugs treatment was used in patients with pulmonary hypertension due to acute exacerbation of lung disease. Recombinant Human Brain Natriuretic Peptide (rhBNP)was approved in 2001 for use in patients with acute heart failure on the basis of studies showing a reduction in pulmonary-capillary wedge pressure(PCWP) and pulmonary arterial pressure (PAP) and improvement cardiac output (CO) . Thus, the study was designed to administer rhBNP as a continuous infusion for 24 hours on pulmonary hypertension of acute exacerbations of chronic pulmonary disease monitoring by Swan- Ganz catheter. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhBNP | Active Comparator | the study is a self controlled study. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.The date of this arm is from the occasion the subject received rhBNP. |
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| Placebo | Placebo Comparator | the study is a self controlled study. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.The date of this arm is from the occasion the subject received placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBNP | Drug | rhBNP was administered as a continuous infusion for 24 hours before or after placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter | we are going to record a change | baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours |
| pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter | we are going to record a change | baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours |
| mean pulmonary artery pressure(mPAP) measured by Swan-Ganz catheter | we are going to record a change | baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours |
| pulmonary vascular resistance(PVR) measured by Swan-Ganz catheter | we are going to record a change | baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours |
| cardiac output(CO) measured by Swan-Ganz catheter | we are going to record a change | baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours |
| Measure | Description | Time Frame |
|---|---|---|
| heat rate (HR) | baseline and 30 hours | |
| respiratory rate(RR) | baseline and 30 hours | |
| blood pressure(BP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LI ZHAO, DOCTOR | SHENJING HOSPTIAL OF CHINA MEDICAL UNIVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenjing Hospital | Shenyang | Liaoning | 110004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24855320 | Background | Haeck ML, Vliegen HW. Diagnosis and treatment of pulmonary hypertension. Heart. 2015 Feb;101(4):311-9. doi: 10.1136/heartjnl-2011-301386. Epub 2014 May 22. No abstract available. | |
| 21732835 | Background | O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalan R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Mendez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171. |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| placebo | Drug | normal saline as a placebo was administered as a continuous infusion for 24 hours |
|
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| baseline and 30 hours |
| blood oxygen saturation(SPO2) | baseline and 30 hours |
| Brog classification | this is a classification table for patient' s feeling of fatigue and dyspnea. from 1 to 10 degree. | baseline and 30 hours |
| Brain Natriuretic Peptide(BNP) in blood | baseline and 30 hours |
| N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood | baseline and 30 hours |
| Potential of Hydrogen(PH) in artery blood gas analysis | baseline and 30 hours |
| arterial partial pressure of oxygen(PaO2) | baseline and 30 hours |
| arterial partial pressure of carbon dioxide (PaCO2) | baseline and 30 hours |
| oxygenation index in artery blood gas analysis | baseline and 30 hours |
| alveolar-arterial oxygen difference in artery blood gas analysis | baseline and 30 hours |
| Background | Mingguang Huang,Yingjun Dong. Clinical observation on rhBNP in treating patients with pulmonary artery hypertension. Shanxi Medical Journal,2011,40(6):545-546. |
| D002318 |
| Cardiovascular Diseases |