NCT00392028

Penetration of Ertapenem Into Bone

Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues

Detailed description

Twelve patients with D.M or P.V.D who are undergoing bellow knee amputation with or without gangrene. Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (TcPO2) on the dorsal side of the mid foot of the affected limb. Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC: * -2 days prior the amputation * -1 day prior the amputation * 1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation. Blood samples (approximately 6ml each) will be collected before Ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery

Conditions

• Amputation

Interventions

Type	Name	Description
DRUG	ertapenem

Timeline

• Start date: 2006-11-01
• Completion: 2007-07-01
• First posted: 2006-10-25
• Last updated: 2007-07-13

Locations

3 sites across 1 country: Israel