The Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation

NCT01774058 | Unknown Phase 2

• 1 other identifier: ILOFLOW2.0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes; Arteriosclerosis; Peripheral Arterial Occlusive Disease; Neuropathy

Keywords

blood flow volume; ilomedin; measurement; intraarterial; neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  6 weeks after surgery

Study Arms (1)

Ilomedin, bloodflow volume, measurement,

EXPERIMENTAL

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

Interventions

Ilomedin DRUG

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)

Also known as: Product Code 1-22460, ATC Code: B01AC11, concentrate and solvent for injection

Ilomedin, bloodflow volume, measurement,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prim PD Dr Afshin Assadian: lead
• Wilhelminenspital Vienna: collaborator

Study Sites (1)

Department of vascular and endovascular surgery, Georg Hagmüller Institute for Vascular Research Wilhelminenhospital

Vienna, 1160, Austria

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Arteriosclerosis; Peripheral Arterial Occlusive Disease 1

Interventions

Solvents; Injections

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Afshin Assadian, Prim PD Dr

  Georg Hagmüller Institute for Vascular Research Wilhelminenhospital Vienna, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Afshin Assadian, Prim. PD Dr.

CONTACT

+34(0)1491504101; afshin.assadian@wienkav.at

Kornelia Hirsch, Dr.

CONTACT

+34(0)1491504101; kornelia.hirsch@wienkav.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prim PD Dr

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 23, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

AU (1)