Intraoperative ICG for Systemic Sclerosis

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 1, 2017

Primary Completion Date

January 23, 2018

Study Completion Date

January 23, 2018

Conditions
Systemic Sclerosis
Interventions
PROCEDURE

Order of two elements of surgical procedure

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

DRUG

Indocyanine Green

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER