Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000572
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
1999-10-27
Brief Title:
Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
Extracorporeal Carbon Dioxide Removal for Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare conventional therapy using low frequency positive pressure ventilation with extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome ARDS
Detailed Description:
BACKGROUND
It is estimated that at least 150000 individuals die each year of adult respiratory distress syndrome Treatment remains largely supportive The National Heart Lung and Blood Institute NHLBI conducted the Extracorporeal Support for Respiratory Insufficiency ECMO Extracorporeal Membrane Oxygenation trial from June 1974 through 1978 In ECMO 90 patients were randomized to either extracorporeal membrane oxygenation plus conventional therapy or to conventional therapy Survival rates were less than ten percent in both groups The failure of the trial to demonstrate the superiority of ECMO over conventional ventilatory support resulted in the virtual elimination of the use of ECMO in clinical medicine
In the earlier NHLBI trial ECMO was implemented with a veno-arterial shunt which approximated 90 percent of the baseline cardiac output Ventilation of the lungs was continued with reduced function of inspiration oxygen Thus the lungs were deprived of the principle source of blood supply while continuously exposed to potentially injurious ventilatory pressures and gas composition The present patient trial used a new form of therapy developed by Dr Gattinoni and co-workers in Milan Italy with the collaboration of Dr Kolobow at the National Institutes of Health in Bethesda The authors reported a 77 percent survival rate for the new therapy In Step 1 of the new therapy the patient was initially ventilated with pressure-controlled inverted ratio ventilation If the patient did not improve Step 2 using extracorporeal perfusion was performed with a veno-venous shunt in contrast to a veno-arterial shunt The veno-venous shunt preserved pulmonary blood flow whereas the veno-arterial shunt diminished it Step 3 was reserved for those patients who did not meet the therapeutic criteria of Step 2 They underwent low frequency positive-pressure ventilation and extracorporeal CO2 removal involving veno-venous bypass via the internal jugular and femoral or bilateral saphenous veins
DESIGN NARRATIVE
Randomized fixed sample Patients were stratified by age under and over 40 years and by the presence or absence of trauma Patients were assigned to conventional positive pressure ventilation therapy or to a three-step therapeutic program employing pressure-controlled-inverted-ratio-ventilation continuous positive airway pressure and low-frequency positive pressure ventilation-extracorporeal CO2 removal The main outcome measure was survival at 30 days after randomization Secondary outcome measures included hospital costs physiologic data length of hospital stay and blood product consumption Follow-up took place during the year after hospital discharge
It is estimated that at least 150000 individuals die each year of adult respiratory distress syndrome Treatment remains largely supportive The National Heart Lung and Blood Institute NHLBI conducted the Extracorporeal Support for Respiratory Insufficiency ECMO Extracorporeal Membrane Oxygenation trial from June 1974 through 1978 In ECMO 90 patients were randomized to either extracorporeal membrane oxygenation plus conventional therapy or to conventional therapy Survival rates were less than ten percent in both groups The failure of the trial to demonstrate the superiority of ECMO over conventional ventilatory support resulted in the virtual elimination of the use of ECMO in clinical medicine
In the earlier NHLBI trial ECMO was implemented with a veno-arterial shunt which approximated 90 percent of the baseline cardiac output Ventilation of the lungs was continued with reduced function of inspiration oxygen Thus the lungs were deprived of the principle source of blood supply while continuously exposed to potentially injurious ventilatory pressures and gas composition The present patient trial used a new form of therapy developed by Dr Gattinoni and co-workers in Milan Italy with the collaboration of Dr Kolobow at the National Institutes of Health in Bethesda The authors reported a 77 percent survival rate for the new therapy In Step 1 of the new therapy the patient was initially ventilated with pressure-controlled inverted ratio ventilation If the patient did not improve Step 2 using extracorporeal perfusion was performed with a veno-venous shunt in contrast to a veno-arterial shunt The veno-venous shunt preserved pulmonary blood flow whereas the veno-arterial shunt diminished it Step 3 was reserved for those patients who did not meet the therapeutic criteria of Step 2 They underwent low frequency positive-pressure ventilation and extracorporeal CO2 removal involving veno-venous bypass via the internal jugular and femoral or bilateral saphenous veins
DESIGN NARRATIVE
Randomized fixed sample Patients were stratified by age under and over 40 years and by the presence or absence of trauma Patients were assigned to conventional positive pressure ventilation therapy or to a three-step therapeutic program employing pressure-controlled-inverted-ratio-ventilation continuous positive airway pressure and low-frequency positive pressure ventilation-extracorporeal CO2 removal The main outcome measure was survival at 30 days after randomization Secondary outcome measures included hospital costs physiologic data length of hospital stay and blood product consumption Follow-up took place during the year after hospital discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL036787 | NIH | None | httpsreporternihgovquickSearchR01HL036787 |