Delirium Clinical Trial
— PODCASTOfficial title:
The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
Verified date | November 2017 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease the chance that patients will experience delirium after their surgery. The investigators are also testing whether ketamine decreases postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length of stay, and adverse outcomes (e.g. hallucinations and nightmares).
Status | Completed |
Enrollment | 746 |
Est. completion date | July 2017 |
Est. primary completion date | June 26, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Patients 60 and older - Competent to provide informed consent - Undergoing major surgery (e.g., open cardiac surgery, open or thoracoscopic thoracic surgery, abdominal surgery, open urological surgery, open gynecological surgery, major orthopedic surgery, major vascular surgery including endovascular procedures, major ear, nose and throat surgery). Exclusion Criteria: - Patients with an allergy to ketamine - Those in whom a significant elevation of blood pressure would constitute a serious hazard (e.g., pheochromocytoma, aortic dissection) - Unable to provide informed consent - Patients with drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin) - Patients taking anti-psychotic medications (e.g., chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone, amisulpride, sertindole) - Patients with a weight outside the range 50 kg - 200 kg (110 lbs - 440 lbs) |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Asan Medical Center, Harvard Medical School, Medical College of Wisconsin, Memorial Sloan Kettering Cancer Center, Postgraduate Institute of Medical Education and Research, University Health Network, Toronto, University of Bern, University of Manitoba, University of Michigan, Virginia Mason Hospital/Medical Center, Weill Medical College of Cornell University |
United States,
Avidan MS, Fritz BA, Maybrier HR, Muench MR, Escallier KE, Chen Y, Ben Abdallah A, Veselis RA, Hudetz JA, Pagel PS, Noh G, Pryor K, Kaiser H, Arya VK, Pong R, Jacobsohn E, Grocott HP, Choi S, Downey RJ, Inouye SK, Mashour GA. The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial. BMJ Open. 2014 Sep 17;4(9):e005651. doi: 10.1136/bmjopen-2014-005651. — View Citation
Avidan MS, Maybrier HR, Abdallah AB, Jacobsohn E, Vlisides PE, Pryor KO, Veselis RA, Grocott HP, Emmert DA, Rogers EM, Downey RJ, Yulico H, Noh GJ, Lee YH, Waszynski CM, Arya VK, Pagel PS, Hudetz JA, Muench MR, Fritz BA, Waberski W, Inouye SK, Mashour GA; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 | According to Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit criteria the number of patients that had any positive CAM on any day for all patients. The main effect evaluated will be to determine whether ketamine decreases delirium, table 3 of the protocol provides a useful guide for the potential findings of the current study with their implications. To further clarify, delirium will be assessed on the day of surgery, when possible and on the subsequent three days POD 1-3, as long as as patients remain in the hospital and are assessable (i.e., not sedated to a RASS <-3). The assessments on POD 1-3 will be done twice daily, once in the morning and once in the afternoon. The primary outcome of the study includes only the delirium incidence on POD 1-3. The primary comparison will be between the combined ketamine groups and the placebo group. |
Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients | |
Secondary | Daily Maximum Pain Recorded | Assessed by observer-based Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) with subsequent administration of patient-reported Visual Analog Scale The behavioral pain scale has three domains and ranges from 3 to 15. The visual analog scale is a continuous scale from 0 to 100 mm. Daily Maximum Pain accounted for pain level in the AM or PM for both the VAS and the BPS/BPS-NI a higher value means a worse outcome. | Postoperative days 1-3, two assessment daily (morning and afternoon), with at least six hours between assessments | |
Secondary | Median Opioid Consumption | Assessed from patients' medical charts. All morphine equivalent drugs consumed by patients perioperatively Opioid Drugs included: * Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg) |
Postoperative days 0-3 | |
Secondary | Number of Patients With Postoperative Nausea and Vomiting | Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they "currently have nausea/vomiting" AM & PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3 The incidence of nausea and or vomiting was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg) for POD 1-3 and overall. |
Postoperative days 1-3 | |
Secondary | ICU and/or Hospital Length of Stay | Assessed from patients' medical charts | Postoperative period | |
Secondary | Adverse Outcomes (Number of Patients With Hallucinations) | Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit | Postoperative days 1-3 | |
Secondary | Adverse Outcomes (Number of Patients With Nightmares) | Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive care Unit | Postoperative days 1-3 |
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