The Intraoperative Arterial Measurement of the Bloodflow After Iloproststimulation in Diabetics and Non-diabetics (ILOFLOW)

This study is currently recruiting participants.
Verified September 2013 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: September 28, 2013
Last verified: September 2013
  Purpose

The investigators think that the blood flow increases during intraarterial injection of iloprost during surgical treatment in distal vessels in patients with arteriosclerosis and diabetes and non diabetes in the same way because of vasodilatation. So the investigators investigate people with arteriosclerosis and diabetes and non diabetes which undergo surgical treatment.


Condition Intervention Phase
Diabetic Gangrene
Arteriosclerosis
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 Bloodflow After Iloproststimulation 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:
  • blood flow volume measurement by ultrasonic test in 60 patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The investigators will measure the blood flow volume with an ultrasonic test instrument in patients which undergo surgical treatment in distal vessels and who gets ilomedin intraarterial into the graft, after 5 and ten minutes directly on the graft. the investigators will investigate 30 diabtics and 30 non-diabetics. The unit is ml/min.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ilomedin, bloodflow volume, measurement
The investigators compare patients with arteriosclerosis and diabetes and non diabetes which undergo surgical treatment in distal vessels. During surgical treatment the investigators measure the bloodflow volume during ilomedin injection intraarterial into the graft. The investigators will use 3000ng ilomedin in 15ml salt water over 2 minutes intraarterial into the new graft and then the investigators will measure the bloodflow volume after 5 and then after 10 minutes again. The investigators think that the blood flow volume increases in the same way in diabetics and non-diabetics.
Drug: Ilomedin
3000ng ilomedin in 15ml salt water will be injected intraarterial into the new graft in the distal vessels over 2 minutes for one time,then the investigators will measure the blood flow after 5 and then after 10 minutesbefore and after the new graft. 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 veine. (10microgramm/o,5ml in 250ml salt water)
Other Names:
  • Ilomedin
  • Product Code 1-22460
  • ATC Code: B01AC11
  • concentrate and solvent for injection

Detailed Description:

The investigators investigate patients with stenosis in distal vessels and diabetes or non diabetes which undergo surgical treatment. During surgery they will get ilomedin intraarterial into the new graft and then the investigators will measure the bloodflow volume after 5 and ten minutes in the distal vessels in front of the graft and after the graft. The investigators will use 3000ng ilomedin in 15ml salt water which should be injected over 2 minutes into the graft. The investigators think that the bloodflow volume will increase in the same way in diabetics and non-diabetics because of the vasodilatation. This would be an important information for these patients to make the therapy better. The patient will be observed by an anesthesiologist during the whole surgery.

Before surgery patients have to agree the participation to this clinical trial and they will get ilomedin intravenous before and after surgery.

  Eligibility

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

Inclusion Criteria:

  • women between 18-99 years
  • men between 18-99 years
  • patients with diabetes and non diabetes
  • patients with arteriosclerosis and who undergo surgical treatment in distal vessels
  • spinal anaesthesia

Exclusion Criteria:

  • pregnancy
  • heart attack in the last 6 months
  • stroke in the last 6 months
  • hypotension
  • edema of the lungs
  • heart failure
  • heart diseases
  • chronic obstructive pulmonary disease (COPD)
  • ulcus ventriculi
  • renal diseases
  • coronary diseases
  • immaturity
  • general anaesthesia
  Contacts and Locations
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
Surgery Departement, 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 Wilhelminenspital 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: September 28, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Wilhelminenspital Vienna:
bloodflow volume
ilomedin
measurement
intraarterial
neuropathy

Additional relevant MeSH terms:
Arteriosclerosis
Gangrene
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014