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This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured in blood and tissue.
Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical wound infection. In this study the dosage of cefuroxime was adjusted to the BMI:
less than 30kg/m*m: 1,5g 31-50kg/m*m: 3,0g more than 50kg/m*m: 4,5g
Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45 minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at the end of surgery (up to 150 minutes after application of Cefuroxime) .
The hypothesis of this study is that adequate drug levels are reached in all groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefuroxime 1,5g | Other | BMI <30kg/m*m |
|
| Cefuroxime 3g | Other | BMI 30-50kg/m*m |
|
| Cefuroxime 4,5g | Other | BMI >50kg/m*m |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefuroxime 1,5g | Drug | Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of Cefuroxime | Drug Serum Level at skin cut | 30-60 minutes after application of cefuroxime |
| Serum level of Cefuroxime | Drug Serum Level 45 minutes after skin cut | 75-105 minutes after application of cefuroxime |
| Serum level of Cefuroxime | Drug Serum Level at the end of surgery | up to 150 minutes after application of cefuroxime |
| Tissue level of Cefuroxime | Drug Tissue Level at skin cut | 30-60 minutes after application of cefuroxime |
| Tissue level of Cefuroxime | Drug Tissue Level 45 minutes after skin cut | 75-105 minutes after application of cefuroxime |
| Tissue level of Cefuroxime | Drug Tissue Level at the end of surgery | up to 150 minutes after application of cefuroxime |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infections | Incidence of surgical site infections | Time until hospital discharge, estimated time period: up to two weeks |
| Hospital Retention period | Length of stay in hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg-Eppendorf | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002444 | Cefuroxime |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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BMI: <30kg/m*m: 1,5g, 31-50kg/m*m: 3,0g, >50kg/m*m: 4,5g
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| Cefuroxime 3g |
| Drug |
Patients with BMI of 30-50kg/m*m: 3g Cefuroxime |
|
| Cefuroxime 4,5g | Drug | Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime |
|
| Time until hospital discharge, estimated time period: 5-7 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |