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The Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation (ILOFLOW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Wilhelminenspital Vienna
Sponsor:
Collaborator:
Wilhelminenspital Vienna
Information provided by (Responsible Party):
Prim PD Dr Afshin Assadian, Wilhelminenspital Vienna
ClinicalTrials.gov Identifier:
NCT01774058
First received: January 7, 2013
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

A prospective case-control study was performed to investigate the effect of iloprost on the intraoperative flow volume in diabetic and non-diabetic patients as well as the effect of peripheral neuropathy in patients with peripheral arterial occlusive disease (PAOD) undergoing arterial reconstruction (primary endpoint).

100 patients undergoing femoral artery reconstruction or femorodistal bypass surgery were included. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow volume at the common femoral artery was assessed using a Doppler flowmeter (Sono TT FlowLab; ) before reconstruction, prior to the intraarterial application of 3000ng of iloprost and 5 and 10 minutes afterwards. Peripheral resistance units (PRU) were calculated as a function of mean systemic arterial pressure (MAP) and flow volume (VF): PRU = MAP (mmHg) / VF (ml/min).


Condition Intervention Phase
Diabetes
Arteriosclerosis
Peripheral Arterial Occlusive Disease
Neuropathy
Drug: Ilomedin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Intraoperative Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation in Diabetics and Non-diabetics: Implication for Outcome-prediction and Perioperative Therapy

Resource links provided by NLM:


Further study details as provided by Wilhelminenspital Vienna:

Primary Outcome Measures:
  • The measurement of the blood flow volume is done with the Sono TT FlowLab (em-Tec GmbH, Munich) ultrasound instrument on the common femoral artery in diabetics and non-diabetics. [ Time Frame: Distal to the injection site doppler flow measurement was performed at the common femoral artery prior to arteriotomy, prior to the intraarterial application of iloprost and 5 and 10 minutes afterwards, using the Sono instrument. ] [ Designated as safety issue: Yes ]
    Before surgery reconstruction the first measurement with the Sono TT FlowLab (em-Tec GmbH, Munich) ultrasound instrument will be done on the common femoral artery and then after surgery reconstruction. Therefore there will be different measuring heads exactly fitting around the vessels. Then the administration of 3000ng Ilomedin® in 15ml saline will be injected into the common femoral artery via a a cannula over two minutes if the systolic blood pressure of the patient is over 100mm Hg. The blood flow volume will be measured again after five and ten minutes on the same point. Those results will be documented.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ilomedin, bloodflow volume, measurement,
Surgery was performed under general anesthesia via a longitudinal skin incision. After systemic administration of 5000 IU of unfractionated Heparin, the peripheral vessels were clamped. Following a longitudinal arteriotomy, thrombendarterectomy of the common femoral artery was performed in all cases, extending into the deep femoral artery and superficial femoral artery when necessary. At the end of the reconstruction, 3000 ng of iloprost (Ilomedin), diluted in 15ml saline solution, were administered into the common femoral artery. Distal to the injection site doppler flow measurement was performed at the common femoral artery prior to arteriotomy, prior to the intraarterial application of iloprost and 5 and 10 minutes afterwards, using the Sono TT FlowLab instrument. During the procedure, systemic arterial blood pressure was continuously documented using a pressure transducer connected to an intraarterial cannula placed in the radial artery of the forearm.
Drug: Ilomedin
3000ng ilomedin in 15ml salt water will be injected intraarterial into the common femoral artery over 2 minutes for one time,then the investigators will measure the blood flow volume after 5 and then after 10 minutes on the common femoral artery. The patients will be observed by the anaesthesiologist. The patient will get ilomedin one day before the surgery and then for 6 day after surgery into the vein. (10microgramm/o,5ml in 250ml salt water)
Other Names:
  • Ilomedin
  • Product Code 1-22460
  • ATC Code: B01AC11
  • concentrate and solvent for injection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with diabetes and non diabetes
  • patients with peripheral artery occlusive disease and who undergo surgical treatment in distal vessels
  • spinal anesthesia
  • written consent

Exclusion Criteria:

  • pregnancy
  • heart attack the last 6 months
  • stroke the last 6 months
  • hypotension
  • edema of the lungs
  • heart failure
  • heart disease
  • chronic obstructive pulmonary disease (COPD)
  • ulcus ventriculi
  • renal disease
  • coronary disease
  • immaturity
  • general anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774058

Contacts
Contact: Afshin Assadian, Prim. PD Dr. +34(0)1491504101 afshin.assadian@wienkav.at
Contact: Kornelia Hirsch, Dr. +34(0)1491504101 kornelia.hirsch@wienkav.at

Locations
Austria
Department of vascular and endovascular surgery, Georg Hagmüller Institute for Vascular Research Wilhelminenhospital Recruiting
Vienna, Austria, 1160
Contact: Afshin Assadian, Prim PD Dr    +34(0)1491504101    afshin.assadian@wienkav.at   
Contact: Kornelia Hirsch, Dr    +34(0)1491504101    kornelia.hirsch@wienkav.at   
Principal Investigator: Afshin Assadian, Prim. PD.Dr         
Sponsors and Collaborators
Prim PD Dr Afshin Assadian
Wilhelminenspital Vienna
Investigators
Principal Investigator: Afshin Assadian, Prim PD Dr Georg Hagmüller Institute for Vascular Research Wilhelminenhospital Vienna, Austria
  More Information

No publications provided

Responsible Party: Prim PD Dr Afshin Assadian, Prim PD Dr, Wilhelminenspital Vienna
ClinicalTrials.gov Identifier: NCT01774058     History of Changes
Other Study ID Numbers: ILOFLOW2.0
Study First Received: January 7, 2013
Last Updated: November 21, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Wilhelminenspital Vienna:
blood flow volume
ilomedin
measurement
intraarterial
neuropathy

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Peripheral Arterial Disease
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014