The Intraoperative Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation in Diabetics and Non-diabetics (ILOFLOW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 23, 2014
Last verified: April 2014
  Purpose

Iloprost® and all those prostaglandins have very good effects in using in the peripheral occlusive diseases (PAOD). Iloprost®, a stable prostacyclin mimetic, is an effective vasodilatator, has anti-thrombotic, leukocyten and endothelium-stabilising properties, reduces reperfusion injury after prolonged ischaemia and improves polyneuropathy and the healing of ulcers which are caused of PAOD. At the current stage it is not clear, which mechanism is predominant for diabetics with or without neuropathy.

This study is undertaken to investigate the increase of the blood flow volume on the common femoral artery after Iloprost® application and surgery reconstruction and therefore investigate the effect for diabetics and none diabetics in order to polyneuropathy. The blood flow will be measured via an ultrasound instrument.


Condition Intervention Phase
Diabetic Gangrene
Arteriosclerosis
Peripheral Occlusive Artery Diseases
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. [ Time Frame: The measurement is done at the beginning of surgery on the common femoral artery, then after 5 and ten minutes after ilomedin administration again. the results are documented. ] [ Designated as safety issue: Yes ]
    Before surgery reconstruction the first measurement with the Sono TT FlowLab (em-Tec GmbH, Munich) ultrasound instrument was done and then after surgery reconstruction. Therefore there were different measuring heads exactly fitting around the vessels. Then the administration of 3000ng Ilomedin® in 15ml saline was injected into the common femoral artery via a a cannula over two minutes if the systolic blood pressure of the patient was over 100mm Hg. The blood flow volume was measured again after five and ten minutes on the same point. Those results were documented.


Estimated Enrollment: 60
Study Start Date: October 2012
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,
Surgery was standardized by performing Thrombendarterectomy in the common femoral artery, profunda and the superficial artery or by performing bypass reconstruction from the common femoral artery after thrombendarterectomy, to the femoropopliteal artery above the knee under general anesthesia with the systemic administration of 5000 IU Heparin before clamping the peripheral vessels. Before surgery reconstruction the first measurement with the Sono TT FlowLab (em-Tec GmbH, Munich) ultrasound instrument was done and then after surgery reconstruction. Therefore there were different measuring heads exactly fitting around the vessels. Then the administration of 3000ng Ilomedin® in 15ml saline was injected into the common femoral artery via a a cannula over two minutes. The blood flow volume was measured again after five and ten minutes on the same point. Those results were documented in ml/min. As well on table-angiography was made.
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

Detailed Description:

This study is a single center, controlled, non- randomized trial evaluating the increase of the blood flow volume on the common femoral artery after admission of 3000ng Ilomedin® intraarterial into the common femoral artery during vascular surgery because of PAOD. All patients provide written informed consent.

General Practitioners and Specialists referred patients to the department. Patients were stratified by their clinical presentation, their walking distance, Doppler index and their angiografie pictures ( PAOD stage IIb-IV of Fontaine). ( PAOD phase IIb was defined because of a walking distance less than 200 metres, and this was measured in this center, III because of pain without walking, IV because of ulcers or gangrene.) All participants were older than eighteen years. Patients who gave their written informed consent underwent a standardized vascular screening, including a health questionnaire and laboratory assessment and a check of the internal specialist and the anestheasia. Before each surgery a measurement of the nerve conduction velocity was performed in order to determine the polyneuropathy. Exclusion criteria comprised immaturity, all exclusion criterias of ilomedin®, pregnancy and spinal anesthesia.

One day before surgery the patients got ilomedin® infusion (2A a 10mg into 250ml saline over 4 hours) intravenous at the department. Surgery was standardized by performing Thrombendarterectomy in the common femoral artery, profunda and the superficial artery or by performing bypass reconstruction from the common femoral artery after thrombendarterectomy, to the femoropopliteal artery above the knee under general anesthesia with the systemic administration of 5000 IU Heparin before clamping the peripheral vessels. Before surgery reconstruction the first measurement with the Sono TT FlowLab (em-Tec GmbH, Munich) ultrasound instrument was done and then after surgery reconstruction. Therefore there were different measuring heads exactly fitting around the vessels. Then the administration of 3000ng Ilomedin® in 15ml saline was injected into the common femoral artery via a a cannula over two minutes if the systolic blood pressure of the patient was over 100mm Hg. The blood flow volume was measured again after five and ten minutes on the same point. Those results were documented. As well on table-angiography was made. Then the skin of the patient was closed.

Before discharge from the hospital every patient was controlled by ultrasound and doppler index and the walking distance and then after six weeks and six months again.

  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 peripheral artery occlusive diseases 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
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
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: April 23, 2014
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
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014