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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-2022-43 | Other Identifier | Wright State University IRB |
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The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events.
The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.
Aim: Prevent 25-46 percent reduction in systolic blood pressure associated with rapid sequence intubation with norepinephrine compared to isotonic fluids alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norepinephrine plus Isotonic Fluids | Experimental | The treatment group will receive a continuous infusion of norepinephrine at 0.10 mcg/kg/min started 2-5 minutes prior to Rapid Sequence Intubation (assuming normal systolic blood pressure 90-140mmHg) in addition to a standard fluid bolus of Lactated Ringers or Normal Saline or Plasmalyte at 999 mL/hr. |
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| Isotonic Fluids | Active Comparator | The control group will receive an infusion of Lactated Ringers or Normal Saline or Plasma-Lyte with at least 500 mL at 999 ml/hr 2-5 minutes prior to Rapid Sequence Intubation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | Norepinephrine continuous infusion at 0.10 mcg/kg/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Change in systolic blood pressure during rapid sequence intubation in mmHg. | 1 hour after Rapid Sequence Intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum creatinine (Acute Kidney Injury) | Change in serum creatinine (in mL) after rapid sequence intubation and development of Acute Kidney Injury as defined by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours | 24 hours after Rapid Sequence Intubation |
| Acute Kidney Injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Koroscil, MD | Wright State University | Principal Investigator |
| Yonatan Dollin, DO | Wright State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Valley Hospital Premier Health | Dayton | Ohio | 45409 | United States |
There is currently no plan to share IPD
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| Lactated Ringers, Intravenous | Drug | 500mL infusion run at 999mL/hr |
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| normal saline | Drug | 500mL infusion run at 999mL/hr |
|
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| Plasma-lyte | Drug | 500mL infusion run at 999mL/hr |
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Change in urine output (in mL) after rapid sequence intubation and development of Acute Kidney Injury as defined by Urine volume <0.5 mL/kg/hour for six hours |
| 24 hours after Rapid Sequence Intubation |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2025 | Feb 14, 2025 | 6 | ||
| Feb 24, 2025 | Mar 10, 2025 | 7 | ||
| Mar 18, 2025 | Mar 27, 2025 | 8 | ||
| Apr 1, 2025 | Apr 14, 2025 | 9 |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D007022 | Hypotension |
| D012769 | Shock |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D000077325 | Ringer's Lactate |
| D000077330 | Saline Solution |
| C012499 | Plasma-lyte 148 |
| C048013 | Plasmalyte A |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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