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This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery. Cefazolin will be administered as a 30-minute intravenous (IV) infusion, per cefazolin Package Insert. Five PK samples per subject will be obtained up to 8 hours after dosing. These data will then be assessed by the validated Cefazolin PK Model to verify there are no significant PK changes within this study population.
This is a Phase 1, open-label, single-dose, multiple-center, study to determine the pharmacokinetics of a single 3 g dose of cefazolin administered as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg. Adult subjects will be enrolled in order to ensure at least 12 subjects complete the study. Enrollment will be competitive across the study sites. All subjects will have Screening and baseline evaluations performed to ensure their eligibility for the study The Screening Period is up to 30 days before administration of study drug on Day 1.
Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). Planned surgical procedures may be performed outpatient or inpatient and are expected to last no longer than 3 hours.
If the surgery is extended unexpectedly beyond the 3-hour limit, additional doses of study drug are permitted according to institutional guidelines. PK blood sample collection will continue after the administration of an additional dose of cefazolin. Safety in this population will also be assessed.
All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min) and 8 h (+/-15 min).
Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests. A follow-up visit will be performed on Day 8 (+/-1 day) for safety assessments.
A subject is considered a study completer if he/she has completed all study related procedures through the end of surgery and the required PK sample collections. It is highly preferred that the subjects also participate in the Day 8 (+/-1 day) Safety Follow-up. For subjects who withdraw or are withdrawn before study completion of the study, every effort will be made to perform all Safety Follow up procedures.
Any subject who withdraws or is withdrawn before collection of at least 4 of the 5 PK samples will not be consider as a PK completer. If necessary, additional subjects must be enrolled to ensure that there are at least 12 PK completers.
On Day 8 (+/-1 day), a Safety follow-up will be conducted. If this is an in-person visit, the following will be performed: vital signs, clinical laboratory tests, examination of the infusion site, review of AEs and concomitant medication. If an in-person visit is not possible, every effort will be made to contact the subject by phone and the subjects will be asked about any AEs and concomitant medication they may have taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefazolin 3gm Injection | Experimental | Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin 3gm for Injection USP and Dextrose Injection USP | Drug | Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg |
| Measure | Description | Time Frame |
|---|---|---|
| Cefazolin Plasma Concentration Following Infusion | Concentrations will be determined through analysis of 5 blood samples drawn at 0.5 (end of infusion), 1, 2, 4, and 8 hours after the start of study drug infusion. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events [Safety] According to Study Protocol | Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests. | 2 days with optional visit on Day 8 |
| Hematology: Hemoglobin (Hb) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IACT Health - Roswell - IACT - HyperCore - PPDS | Columbus | Georgia | 31904 | United States | ||
| Hightower Clinical, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12698406 | Background | Haessler D, Reverdy ME, Neidecker J, Brule P, Ninet J, Lehot JJ. Antibiotic prophylaxis with cefazolin and gentamicin in cardiac surgery for children less than ten kilograms. J Cardiothorac Vasc Anesth. 2003 Apr;17(2):221-5. doi: 10.1053/jcan.2003.51. | |
| 26971263 | Background | Kamath VH, Cheung JP, Mak KC, Wong YW, Cheung WY, Luk KD, Cheung KM. Antimicrobial prophylaxis to prevent surgical site infection in adolescent idiopathic scoliosis patients undergoing posterior spinal fusion: 2 doses versus antibiotics till drain removal. Eur Spine J. 2016 Oct;25(10):3242-3248. doi: 10.1007/s00586-016-4491-7. Epub 2016 Mar 12. |
| Label | URL |
|---|---|
| Nahata MC, Winters CB, Powell DA. Variation in prophylactic antibiotic use in pediatric orthopedic surgery. Drug Intell Clin Pharm. 1985;19(11):834-6 | View source |
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There were no pre-assignment activities for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cefazolin 3gm Injection | Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min). Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cefazolin 3gm Injection | Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min). Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg |
| 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 | Cefazolin Plasma Concentration Following Infusion | Concentrations will be determined through analysis of 5 blood samples drawn at 0.5 (end of infusion), 1, 2, 4, and 8 hours after the start of study drug infusion. | Only one (1) subject agreed to the 8-hour PK blood sample. | Posted | Mean | Standard Deviation | ug/mL | 8 hours |
|
Data were collected from signing of consent through the follow-up visit on End of Study (Day 8).
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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 | Cefazolin 3gm Injection | Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min). Cefazolin 3gm for Injection USP and Dextrose Injection USP: Cefazolin 3gm for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur once as a 30 minute IV infusion prior to surgery in adult subjects weighing >/= 120 kg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Scientific Affairs Operations | B. Braun Medical Inc. | 610-596-2512 | kevin.minnich@bbraunusa.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2021 | Mar 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2022 | Mar 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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This is an open-label, non-randomized pharmacokinetic study. All subjects will be receiving the same study treatment, thus blinding is unnecessary.
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This is an open-label, non-randomized pharmacokinetic study. All subjects will be receiving the same study treatment, thus masking is unnecessary.
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|
gm/L |
| 2 days with optional visit on Day 8 |
| Hematology: Hematocrit (Hct) | 2 days with optional visit on Day 8 |
| Hematology: Mean Corpuscular Volume (MCV) | fL | 2 days with optional visit on Day 8 |
| Hematology: Mean Corpuscular Hemoglobin (MCH) | pg | 2 days with optional visit on Day 8 |
| Hematology: Mean Corpuscular Hemoglobin Concentration | mmol/L | 2 days with optional visit on Day 8 |
| Hematology: Platelet Count | platelets / L | 2 days with optional visit on Day 8 |
| Hematology: RBC | cells/L | 2 days with optional visit on Day 8 |
| Hematology: WBC | cells/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Sodium | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Potassium | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Chloride | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: CO2 (Bicarbonate) | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Glucose | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: ALT | IU/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: AST | IU/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Creatine Phosphokinase (CPK) | ukat / L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Lactic Acid Dehydrogenase (LDH) | IU/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Albumin | g/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Alkaline Phosphatase | IU/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Uric Acid | umol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Calcium | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Phosphate | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Total Protein | g/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Total Bilirubin | micro-mol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Blood Urea Nitrogen | mmol/L | 2 days with optional visit on Day 8 |
| Clinical Chemistry: Creatinine | micro-mol/L | 2 days with optional visit on Day 8 |
| Vital Signs: Temperature | Degree centigrade | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
| Vital Signs: Blood Pressure (Systolic) | mm Hg | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
| Vital Signs: Heart Rate | Beats per minute | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
| Vital Signs: Respiratory Rate | Breaths per minute | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
| Vital Signs: Weight | kg | Baseline |
| Vital Signs: Height | cm | Baseline |
| Vital Signs: BMI | kg/cm^2 | Baseline |
| ECG: PR Interval | msec | 2 days |
| ECG: QRS Duration | msec | 2 days |
| ECG: QT Interval | msec | 2 days |
| Urine Pregnancy Test | (If appropriate) If positive, a confirmatory serum test will be performed. | Baseline |
| Vital Signs: Blood Pressure (Diastolic) | mm Hg | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
| Oklahoma City |
| Oklahoma |
| 73102 |
| United States |
| 4201317 | Background | Khan AJ. Clinical and laboratory evaluation of cefazolin: a new cephalosporin antibiotic in pediatric patients. Curr Ther Res Clin Exp. 1973 Oct;15(10):727-33. No abstract available. |
| 3437384 | Background | Koshida R, Nakashima E, Ichimura F, Nakano O, Watanabe R, Taniguchi N, Tsuji A. Comparative distribution kinetics of cefazolin and tobramycin in children. J Pharmacobiodyn. 1987 Sep;10(9):436-42. doi: 10.1248/bpb1978.10.436. |
| 7603806 | Background | Lee KR, Ring JC, Leggiadro RJ. Prophylactic antibiotic use in pediatric cardiovascular surgery: a survey of current practice. Pediatr Infect Dis J. 1995 Apr;14(4):267-9. doi: 10.1097/00006454-199504000-00004. |
| 2644371 | Background | Leggett JE, Fantin B, Ebert S, Totsuka K, Vogelman B, Calame W, Mattie H, Craig WA. Comparative antibiotic dose-effect relations at several dosing intervals in murine pneumonitis and thigh-infection models. J Infect Dis. 1989 Feb;159(2):281-92. doi: 10.1093/infdis/159.2.281. |
| 12400768 | Background | Maher KO, VanDerElzen K, Bove EL, Mosca RS, Chenoweth CE, Kulik TJ. A retrospective review of three antibiotic prophylaxis regimens for pediatric cardiac surgical patients. Ann Thorac Surg. 2002 Oct;74(4):1195-200. doi: 10.1016/s0003-4975(02)03893-6. |
| 9261702 | Background | Rodgers GL, Fisher MC, Lo A, Cresswell A, Long SS. Study of antibiotic prophylaxis during burn wound debridement in children. J Burn Care Rehabil. 1997 Jul-Aug;18(4):342-6. doi: 10.1097/00004630-199707000-00012. |
| 877649 | Background | Ross S, Rodriguez W, Khan W. The cephalosporin antibiotics in pediatric practice. South Med J. 1977 Jul;70(7):855-61. doi: 10.1097/00007611-197707000-00026. |
| 25941220 | Background | Schmitz ML, Blumer JL, Cetnarowski W, Rubino CM. Determination of appropriate weight-based cutoffs for empiric cefazolin dosing using data from a phase 1 pharmacokinetics and safety study of cefazolin administered for surgical prophylaxis in pediatric patients aged 10 to 12 years. Antimicrob Agents Chemother. 2015 Jul;59(7):4173-80. doi: 10.1128/AAC.00082-15. Epub 2015 May 4. |
| 33202066 | Background | Schmitz ML, Rubino CM, Onufrak NJ, Martinez DV, Licursi D, Karpf A, Cetnarowski W. Pharmacokinetics and Optimal Dose Selection of Cefazolin for Surgical Prophylaxis of Pediatric Patients. J Clin Pharmacol. 2021 May;61(5):666-676. doi: 10.1002/jcph.1785. Epub 2020 Dec 9. |
| Nahata MC, Durrell DE, Ginn-Pease ME, et al. Pharmacokinetics and tissue concentrations of cefazolin in pediatric patients undergoing gastrointestinal surgery. Eur J Drug Metab Pharmacokinet. 1991;16(1):49-52 | View source |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events [Safety] According to Study Protocol | Safety will be assessed by monitoring adverse events (AEs), physical examination, vital signs, and clinical laboratory tests. | Posted | Count of Participants | Participants | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: Hemoglobin (Hb) | gm/L | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | gm/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: Hematocrit (Hct) | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | ratio | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: Mean Corpuscular Volume (MCV) | fL | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Error | fL | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: Mean Corpuscular Hemoglobin (MCH) | pg | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | pg | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: Mean Corpuscular Hemoglobin Concentration | mmol/L | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | mmol/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: Platelet Count | platelets / L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | 10^9 platelets/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: RBC | cells/L | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | 10^12 cells / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Hematology: WBC | cells/L | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | 10^9 cells / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Sodium | mmol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | mmol / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Potassium | mmol/L | Medical staff only obtained clinical labs from 7 subjects | Posted | Mean | Standard Deviation | mmol / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Chloride | mmol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | mmol / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: CO2 (Bicarbonate) | mmol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | mmol / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Glucose | mmol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | mmol / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: ALT | IU/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | IU / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: AST | IU/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | IU / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Creatine Phosphokinase (CPK) | ukat / L | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | ukat / L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Lactic Acid Dehydrogenase (LDH) | IU/L | Medical staff only obtained clinical labs from 5 subjects | Posted | Mean | Standard Deviation | IU/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Albumin | g/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | g/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Alkaline Phosphatase | IU/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | IU/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Uric Acid | umol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | umol/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Calcium | mmol/L | Medical staff only obtained clinical labs from 7 subjects | Posted | Mean | Standard Deviation | mmol/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Phosphate | mmol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | mmol/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Total Protein | g/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | g/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Total Bilirubin | micro-mol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | micro-mol/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Blood Urea Nitrogen | mmol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | mmol/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Clinical Chemistry: Creatinine | micro-mol/L | Medical staff only obtained clinical labs from 6 subjects | Posted | Mean | Standard Deviation | Umol/L | 2 days with optional visit on Day 8 |
|
|
|
| Secondary | Vital Signs: Temperature | Degree centigrade | Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint | Posted | Mean | Standard Deviation | degrees centrigrade | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
|
|
|
| Secondary | Vital Signs: Blood Pressure (Systolic) | mm Hg | Medical staff only obtained BP from 2 subjects at the 8-hour post-infusion timepoint | Posted | Mean | Standard Deviation | mm Hg | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
|
|
|
| Secondary | Vital Signs: Heart Rate | Beats per minute | Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint | Posted | Mean | Standard Deviation | beats per minute | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
|
|
|
| Secondary | Vital Signs: Respiratory Rate | Breaths per minute | Medical staff only obtained temperature from 2 subjects at the 8-hour post-infusion timepoint | Posted | Mean | Standard Deviation | Breaths per minute | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
|
|
|
| Secondary | Vital Signs: Weight | kg | Posted | Mean | Standard Deviation | kg | Baseline |
|
|
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| Secondary | Vital Signs: Height | cm | Posted | Mean | Standard Deviation | cm | Baseline |
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| Secondary | Vital Signs: BMI | kg/cm^2 | Posted | Mean | Standard Deviation | kg/cm^2 | Baseline |
|
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| Secondary | ECG: PR Interval | msec | Posted | Mean | Standard Deviation | msec | 2 days |
|
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| Secondary | ECG: QRS Duration | msec | Posted | Mean | Standard Deviation | msec | 2 days |
|
|
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| Secondary | ECG: QT Interval | msec | Posted | Mean | Standard Deviation | msec | 2 days |
|
|
|
| Secondary | Urine Pregnancy Test | (If appropriate) If positive, a confirmatory serum test will be performed. | Pregnancy was an exclusionary criteria. All women enrolled where either post-menopausal or had a negative pregnancy test. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | Vital Signs: Blood Pressure (Diastolic) | mm Hg | Medical staff only obtained BP from 2 subjects at the 8-hour post-infusion timepoint | Posted | Mean | Standard Deviation | mm Hg | Baseline; post-infusion at 30-minutes, 2-hours, 4-hours, and 8-hours; post-surgery |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
Study data may be considered for reporting or publication. Sponsor will be responsible for these activities and may work with the investigators to determine how the manuscript is written, the number and order of authors, the journal, and other related issues. The sponsor has final approval authority over all such issues.
Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, which shall be in the sponsor's sole discretion.
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| Post-Infusion, 2-hr |
|
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| Post-Infusion, 4-hr |
|
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| Post-Infusion, 8-hr |
|
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| End of Surgery |
|
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|
| Post-Infusion, 2-hr |
|
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| Post-Infusion, 4-hr |
|
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| Post-Infusion, 8-hr |
|
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| End of Surgery |
|
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| Post-Infusion, 2-hr |
|
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| Post-Infusion, 4-hr |
|
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| Post-Infusion, 8-hr |
|
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| End of Surgery |
|
|
|
| Post-Infusion, 2-hr |
|
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| Post-Infusion, 4-hr |
|
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| Post-Infusion, 8-hr |
|
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| End of Surgery |
|
|
|
| Post-Infusion, 2-hr |
|
|
| Post-Infusion, 4-hr |
|
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| Post-Infusion, 8-hr |
|
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| End of Surgery |
|
|