Intraoperative ICG for Systemic Sclerosis

NCT03155464 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Pro00078686
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the relative intraoperative improvement in perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a one to one randomized study design. There is the potential risk of loss of confidentiality. The study involves the intraoperative assessment of perfusion by quantitative ICG. ICG is FDA approved for this usage and will be used according to its labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and patient and physician assessments. There are no additional physical risks associated with participating in this study over and above that of the planned arterial reconstruction (bypass) and sympathectomies.The information collected will be kept confidential and will comply with the HIPAA.

Conditions

Systemic Sclerosis

Keywords

indocyanine-green; systemic scerlosis

Outcome Measures

Primary Outcomes (1)

• Change in perfusion

  To compare the relative intraoperative change in perfusion between arterial reconstruction and sympathectomies with quantitative ICG.

  Baseline-One Year Follow-up

Secondary Outcomes (1)

• Intraoperative change in hand and digit perfusion

  Baseline-One Year Follow-up

Other Outcomes (7)

• Comparison of clinical and intraoperative quantitative ICG measurements

  Baseline-One Year Follow-up

• Change in Michigan Hand Outcome Questionnaire

  Baseline-One Year Follow-up

• Change in Visual Analogue Scale for Pain (VAS)

  Baseline-One Year Follow-up

Study Arms (2)

Group 1

OTHER

Order of two elements of surgical procedure: patients in group 1 will receive sympathectomy prior to bypass during the surgical procedure. Indocyanine Green (ICG) will be used in both groups.

Procedure: Order of two elements of surgical procedure; Drug: Indocyanine Green

Group 2

OTHER

Order of two elements of surgical procedure: Patients in group 2 will receive bypass prior to sympathectomy during the surgical procedure. Indocyanine Green (ICG) will be used in both groups.

Procedure: Order of two elements of surgical procedure; Drug: Indocyanine Green

Interventions

Order of two elements of surgical procedure PROCEDURE

Please see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2.

Group 1; Group 2

Indocyanine Green DRUG

Intraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.

Also known as: ICG

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• o Patient has signed an IRB approved, study specific Informed Patient Consent Form.
• Patient is a male or non-pregnant female age 18 - 85 years at time of study enrollment.
• Patient has a diagnosis of a systemic sclerosis with vascular obstruction of the hand resulting in digital ischemia, ulceration, and/or gangrene and have failed nonoperative treatments.
• Patient is willing and able to comply with postoperative scheduled clinical evaluations.

You may not qualify if:

• Patient is undergoing revision surgery.
• Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
• If, during surgery, the arterial reconstruction could not be performed because the vessel was damaged to the point where there was no appropriate site for a bypass anastomosis.
• Patient is a prisoner
• Pregnant women confirmed by testing prior to surgery, and nursing mothers
• Patient has an allergy to iodine confirmed during initial history and on day of surgery

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Suhail Mithani, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 16, 2017
• Study Start: June 1, 2017
• Primary Completion: January 23, 2018
• Study Completion: January 23, 2018
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share