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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Northern California Institute of Research and Education | OTHER |
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Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.
Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations.
This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.
The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol Hydrochloride | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol Hydrochloride | Drug | Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery. On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth). On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth). On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth). On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth). This will complete the course of propranolol. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of Stay | Measured using patient medical records | Truncated at 30 days after admission to ICU |
| Hospital Length of Stay | Measured using patient medical records | Truncated at 30 days after admission to ICU |
| Postoperative Delirium | Measured using Confusion Assessment Method (CAM-CAM-ICU) | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Postoperative Renal Dysfunction | Measured using Serum Creatinine laboratory values | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Complications | Measured using patient medical records | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Pain Intensity | Pain intensity was measured using a Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible. |
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Inclusion Criteria:
Exclusion Criteria:
Veterans will be excluded if:
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| Name | Affiliation | Role |
|---|---|---|
| Marek Brzezinski, M.D., Ph.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
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A total of 14,504 patients were screened for eligibility with 126 providing written consent and undergoing PDS assessment and 83 subjects potentially meeting inclusion criteria. Of those 83, 24 subjects were not found to not meet inclusion criteria due to postponement in surgery, change in condition, or due to the stress associated with talking about the trauma. Ultimately, only 59 participants met all inclusion criteria and were enrolled out of the originally planned 110 subjects anticipated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propranolol Hydrochloride | Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery. On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth). On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth). On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth). On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth). This will complete the course of propranolol. |
| FG001 | Placebo Group | Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth. On post operative days #1-13, patients will take one placebo pill (once daily by mouth). This will complete the course of the placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propranolol Hydrochloride | Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery. On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth). On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth). On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth). On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth). This will complete the course of propranolol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ICU Length of Stay | Measured using patient medical records | Posted | Mean | Standard Deviation | days | Truncated at 30 days after admission to ICU |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propranolol Hydrochloride | Propranolol Hydrochloride: Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery. On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth). On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth). On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth). On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth). This will complete the course of propranolol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marek Brzezinski, MD, PhD | University of California, San Francisco | 415-221-4810 | 4454 | Marek.Brzezinski@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 | Sep 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2019 | Sep 22, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| C477592 | propranolol CR |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
|
| Placebo | Other | The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth. On post operative days #1-13, patients will take one placebo pill (once daily by mouth). This will complete the course of the placebo. |
|
| 12 months |
| Pain Unpleasantness | Measured using the Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible. | 12 months |
| Perioperative Opioids Use | Measured using patient medical records. | Participants will be followed from preoperative baseline to 1 year postoperative |
| Required Mechanical Ventilation | Measured using patient medical records | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Change in Posttraumatic Diagnostic Scale (PDS) PTSD Symptoms Severity Score | The Posttraumatic Diagnostic Scale (PDS) Scale includes a PTSD Symptoms Severity Score ranging from 0 to 51, with higher scores indicating more severe depression. | Baseline and 12 months |
| Change in Mental Component Summary (MCS) Scores From the Short Form-36 Questionnaire (SF-36) | The Mental Component Summary (MCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better mental health and lower scores indicating worse mental health. | Participants will be followed from preoperative baseline to 1 year postoperative |
| Change in Physical Component Summary (PCS) Scores From the Short Form-36 Questionnaire (SF-36) | The Physical Component Summary (PCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical health and lower scores indicating worse physical health. | Participants will be followed from preoperative baseline to 1 year postoperative |
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire assessing sleep quality. Total scores range from 0 to 21, with higher scores indicating worse sleep quality and lower scores indicating better sleep quality | Participants will be followed from preoperative baseline to 1 year postoperative |
| Change in Beck Depression Inventory (BDI) Score | The Beck Depression Inventory (BDI) is a validated self-report measure of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome) and lower scores indicating fewer or minimal symptoms (better outcome). | Participants will be followed from preoperative baseline to 1 year postoperative |
| Postoperative Neurocognitive Dysfunction Score | The Mini-Mental State Examination (MMSE) is a widely used screening tool for cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment. | Participants will be followed from preoperative baseline to 1 year postoperative |
| 30-day, 3-month, and 1-year Mortality | Measured using patient medical records | Participants will be followed from preoperative baseline to 1 year postoperative |
| Postoperative Complications | Measured using patient medical records - Composite outcome measure that included, delirium, stroke, myocardial infarction, acute kidney injury, new atrial fibrilation, infection, or congestive heart failure between the surgery and 1-yr. | Participants will be followed to 1 year postoperative |
| BG001 | Placebo Group | Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth. On post operative days #1-13, patients will take one placebo pill (once daily by mouth). This will complete the course of the placebo. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Group | Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth. On post operative days #1-13, patients will take one placebo pill (once daily by mouth). This will complete the course of the placebo. |
|
|
| Primary | Hospital Length of Stay | Measured using patient medical records | Posted | Mean | Standard Deviation | days | Truncated at 30 days after admission to ICU |
|
|
|
| Primary | Postoperative Delirium | Measured using Confusion Assessment Method (CAM-CAM-ICU) | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
|
|
|
| Primary | Postoperative Renal Dysfunction | Measured using Serum Creatinine laboratory values | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
|
|
|
| Secondary | Perioperative Complications | Measured using patient medical records | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
|
|
|
| Secondary | Pain Intensity | Pain intensity was measured using a Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Pain Unpleasantness | Measured using the Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible. | The 12 month survey response rate was low. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Perioperative Opioids Use | Measured using patient medical records. | Posted | Count of Participants | Participants | Participants will be followed from preoperative baseline to 1 year postoperative |
|
|
|
| Secondary | Required Mechanical Ventilation | Measured using patient medical records | Posted | Count of Participants | Participants | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
|
|
|
| Secondary | Change in Posttraumatic Diagnostic Scale (PDS) PTSD Symptoms Severity Score | The Posttraumatic Diagnostic Scale (PDS) Scale includes a PTSD Symptoms Severity Score ranging from 0 to 51, with higher scores indicating more severe depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months |
|
|
|
| Secondary | Change in Mental Component Summary (MCS) Scores From the Short Form-36 Questionnaire (SF-36) | The Mental Component Summary (MCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better mental health and lower scores indicating worse mental health. | Posted | Mean | Standard Deviation | Score on a scale | Participants will be followed from preoperative baseline to 1 year postoperative |
|
|
|
| Secondary | Change in Physical Component Summary (PCS) Scores From the Short Form-36 Questionnaire (SF-36) | The Physical Component Summary (PCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical health and lower scores indicating worse physical health. | Posted | Mean | Standard Deviation | Score on a scale | Participants will be followed from preoperative baseline to 1 year postoperative |
|
|
|
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) Score | The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire assessing sleep quality. Total scores range from 0 to 21, with higher scores indicating worse sleep quality and lower scores indicating better sleep quality | Posted | Mean | Standard Deviation | Score on a scale | Participants will be followed from preoperative baseline to 1 year postoperative |
|
|
|
| Secondary | Change in Beck Depression Inventory (BDI) Score | The Beck Depression Inventory (BDI) is a validated self-report measure of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome) and lower scores indicating fewer or minimal symptoms (better outcome). | Posted | Mean | Standard Deviation | Score on a scale | Participants will be followed from preoperative baseline to 1 year postoperative |
|
|
|
| Secondary | Postoperative Neurocognitive Dysfunction Score | The Mini-Mental State Examination (MMSE) is a widely used screening tool for cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment. | There were 5 participants with data available for this outcome measure at 1 year. | Posted | Mean | Standard Deviation | score on a scale | Participants will be followed from preoperative baseline to 1 year postoperative |
|
|
|
| Secondary | 30-day, 3-month, and 1-year Mortality | Measured using patient medical records | Posted | Count of Participants | Participants | Participants will be followed from preoperative baseline to 1 year postoperative |
|
|
|
| Secondary | Postoperative Complications | Measured using patient medical records - Composite outcome measure that included, delirium, stroke, myocardial infarction, acute kidney injury, new atrial fibrilation, infection, or congestive heart failure between the surgery and 1-yr. | There were 5 missing values for this measure 2 from the Propranolol group and 3 from the Placebo group. | Posted | Count of Participants | Participants | Participants will be followed to 1 year postoperative |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo Group | Placebo: The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth. On post operative days #1-13, patients will take one placebo pill (once daily by mouth). This will complete the course of the placebo. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| 1 year |
|