Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers (NCT06216366) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
United States36 participantsStarted 2025-08-15
Plain-language summary
Healthy trained SCUBA divers will be randomized into three groups and exposed to a high-pressure profile in a hyperbaric chamber. The high-pressure profile simulates the pressure at a depth of 30 meters of sea water (MSW) for 35 minutes. In the control group, the subjects will receive intravenous normal saline immediately before and after the high-pressure exposure. The second group will receive intravenous recombinant human gelsolin (rhu-pGSN) 24 mg/kg immediately prior to the exposure, and saline post-exposure. The third group will receive saline pre-exposure and rhu-pGSN post-exposure. Blood samples will be collected at multiple time points pre- and post-exposure to assess levels of inflammatory markers, including interleukin (IL)-1β. Other assessments include screening for gas bubbles, a validated questionnaire to assess the incidence of clinical decompression sickness (DCS), measurement of plasma gelsolin (pGSN) levels, and measurement of anti-pGSN antibodies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Experienced healthy trained female or male SCUBA divers without known underlying comorbidities
✓. Age ≥18
✓. Informed consent obtained from subject
✓. During the course of the study starting at screening and for at least 3 months after their final study treatment:
Exclusion criteria
✕. Any co-morbidity contraindicating SCUBA diving
✕. Pregnant or lactating women
✕. History of unrepaired cardiac shunt or echocardiographic evidence of patent foramen ovale or atrial septal defect
✕. Any active underlying conditions including but not limited to cancer or other illness treated with systemic chemotherapy, immunomodulatory biologics, or radiation therapy during the last 360 days or expected to be treated in the upcoming 120 days
✕. Refusal or inability to use adequate contraception
What they're measuring
1
Interleukin (IL)-1β
Timeframe: At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14