Patients are divided in 6 groups of 3 patients to receive the following intervention: 0 gram (g), 2.5 g, 5 g, 10 g, 12.5 g and 15 g of sodium thiosulfate pentahydrate (STS) intravenous. The first dose is given in 15 min immediately after inclusion at the cath-lab. In the absence of dose-limiting toxicity (DLT), a second gift of STS is given in 30 min, 6 hours later at the coronary care unit (CCU). When no DLT is observed in any of the patients after 2 gifts of the same dose an extra 3 subjects are enrolled into the next higher dose cohort. If 1 out of 3 patient develops DLT at a specific dose, an extra 3 subjects are enrolled into the same dose cohort. When more than 1 out of 6 patients develop DLT the trial will be terminated because the maximum tolerable dose (MTD) has been exceeded.

Acute Coronary Syndrome

Sodium Thiosulfate Pentahydrate is administered intravenously in 250 centiliters infusion fluid in two doses: first dose with an infusion rate of 16.66 milliliter (ml) per minute (min), second dose with 8.33 ml / min

Sodium Thiosulfate Pentahydrate

University Medical Centre Groningen

Safety and Tolerability of Sodium Thiosulfate in Patients With an ACS Undergoing CAG Via Trans-radial Approach.

Safety and Tolerability of Sodium Thiosulfate in Patients Presenting With an Acute Coronary Syndrome Undergoing Coronary Angiography Via Trans-radial Approach: a Dose-escalation Study.

DLT defined as all-cause mortality or hemodynamic instability of significant clinical impact:
Hemodynamic instability of significant clinical impact is defined as:
Systolic blood pressure <90 millimeters mercury (mmHg) for >30 min and/or
Catecholamines required to maintain pressure >90 mmHg during systole and
Signs of pulmonary congestion or elevated left-ventricular filling pressures and;
Signs of impaired organ perfusion with ≥1 of the following criteria:
Confusion;
Cool, clammy skin;
Oliguria (urine output <30 ml/h);
Serum-lactate >2.0 mmol/l.
Shock of other causes (hypovolemia, sepsis, bradycardia) are ruled out.

Severe hypersensitivity/allergic reaction such as angio-edema, heavy itch/rash. Outcome measurement will assessed using a binary scale: present (yes) or absent (no)

using a 4-point Likert-scale: 0= none, 1= nauseated but able to eat and/or 1 episode of vomiting in 24 hours, 2= food intake significantly decreased and/or 2-5 episodes of vomiting in 24 hours, 3= intravenous fluids required and/or >5 episodes of vomiting in 24 hours

effect of STS on oxidative stress markers in blood by laboratory analysis of free thiols in blood. Unity: µmol/l. Measurement on different timeframes, starting at T=0, to evaluate the effect of STS on free thiol levels in blood.

Pim van der Harst

Prof. dr.

University Medical Center Groningen

Inspired oxygen fraction > 0.5 and SpO2 = 98-100%

Air or lowest possible inspired concentration of oxygen to maintain SpO2 > 90%

Vascular Disease

Oxygen in sufficient quantity to maintain SpO2 > 98%

Oxygen

Supplemental Oxygen in sufficient quantity to maintain SpO2 > 90%

University Hospital

Örebro University Hospital

Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications?

Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications? A Randomised, Prospective Study in Patients Undergoing Vascular Surgery

Major complications such as MACE, TIA/stroke/renal insufficiency/POCD etc

renal insufficiency including dialysis or renal failure

Anil Gupta

Associate Professor

Örebro University, Sweden

whole blood, serum, white cells, red blood cells, urine, breast milk, meconium

Exposure to Environmental Pollution

Rambam Medical Center

Lis Medical Center

Assaf Harofeh Medical Center

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

assessment of BFRs and phthalates body burdens through measurement of these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and neonatal meconium among several representative sub-populations

To examine associations between exposure to PBDEs and phthalates and (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted for gestational age, ponderal index, head circumference adjusted for gestational age), and (c) cryptorchidism incidence, (d) maternal and infant thyroid function

To establish a bio repository of these media for future studies and to establish follow up methods for this cohort to later assess development and growth in the infants, toddlers and children

Assaf-Harofeh Medical Center

This is the only arm and involves active treatment with sodium thiosulfate in those subjects with high coronary artery calcium scores.

Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.

Sodium Thiosulfate

Sex: Female, Male

Region of Enrollment

We will compare the annualized coronary calcium volume score obtained at the baseline CT of the coronary arteries with another CT obtained of the same coronary arteries following 5 months of sodium thiosulfate treatment.

Treatment with sodium thiosulfate after each dialysis for 5 months

Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.

Overall Study

James Delmez, MD

Complication of Hemodialysis

Cardiovascular Diseases

sodium thiosulfate 12.5-25 gm/M2 after each thrice weekly hemodialysis treatments for 5 months.

sodium thiosulfate

Effects of Sodium Thiosulfate on Vascular Calcification in End-Stage Renal Disease: A Pilot Study of Feasibility, Safety and Efficacy: Am J Nephrol 2011;33:131-138

Sodium thiosulfate delays the progression of coronary artery calcification in haemodialysis patients -Nephrol. Dial. Transplant. (2010) 25(6): 1923-1929 first published online January 18, 2010 doi:10.1093/ndt/gfp755

cyanide/nelabums

Safety and Tolerability of Sodium Thiosulfate in Patients With an ACS Undergoing CAG Via Trans-radial Approach.

Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications?

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

Sodium Thiosulfate Treatment of Vascular Calcification in ESRD

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