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

This study is currently recruiting participants.
Verified May 2016 by Prim PD Dr Afshin Assadian, Wilhelminenspital Vienna
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774058
First Posted: January 23, 2013
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Wilhelminenspital Vienna
Information provided by (Responsible Party):
Prim PD Dr Afshin Assadian, Wilhelminenspital Vienna
  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: None (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 Prim PD Dr Afshin Assadian, 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 after ilomedin administration. [ Time Frame: 6 weeks after surgery ]
    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: October 2016
Estimated Primary Completion Date: October 2016 (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:
  • Product Code 1-22460
  • ATC Code: B01AC11
  • concentrate and solvent for injection

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 7, 2013
First Posted: January 23, 2013
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Prim PD Dr Afshin Assadian, Wilhelminenspital Vienna:
blood flow volume
ilomedin
measurement
intraarterial
neuropathy

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