How do restrictive versus liberal strategies of intravenous calcium supplementation affect time of shock resolution and hemodynamic parameters in septic shock patients? hypocalcemia, sepsis, septic shock, time of shock resolution, ionized calcium
Conditions
Interventions
In the restrictive strategy group, intravenous calcium gluconate will be administered to each patient once their blood gas results confirm that the ionized calcium level is 0.9 mmol/L or lower. The tr
Experimental Drug,Experimental Drug
Restrictive group,Liberal group
Sponsors
Faculty of Medicine, Khon Kaen University.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older. 2. Patients who meet the clinical criteria for septic shock, defined below, and already monitored with invasive blood pressure monitoring. 3. Patients who have asymptomatic hypocalcemia, which is defined as a single measurement of ionized calcium levels below 1.15 mmol/L from arterial blood gas analysis.
Exclusion criteria
Exclusion criteria: 1. Patients previously diagnosed with parathyroid disorders: hyperparathyroidism or previously known parathyroid hormone level more than 5 times the upper normal limit (325 pg/mL) 2. Patients who are currently receiving continuous calcium infusions or total parenteral nutrition 3. Patients who used bisphosphonate last year before enrollment. 4. Patients diagnosed with chronic kidney disease (CKD) stage 4 or 5, or those who require renal replacement therapy 5. Patients are diagnosed with terminal illness or palliative care, with a prognosis of less than six months. Or A Do Not Resuscitate (DNR) order has also been prescribed by the patient's wishes 6. Pregnancy (every woman who was enrolled in the study was checked using urine pregnancy tests) 7. Patients who refuse to engage in the study or cannot identify legally authorized representatives (LAR) within 24 hours 8. Patients who meet criteria for septic shock more than 24 hours. 9. Patients who have cardiac arrest within 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of shock resolution at resolving of shock hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamic parameters (mean arterial pressure) at 30, 60, 90 minutes, post calcium infusion at 30, 60, 90 minutes, post calcium infusion mmHg,Difference of ionized calcium concentration at each monitoring Delta ionized calcium every 6 hours Delta ionized calcium every 6 hours,Lactate clearance, post calcium infusion every 6 hours Lactate clearance,Difference of Sequential Organ Failure Assessment at 72 hours after randomization at 72 hours after randomization Delta Sequential Organ Failure Assessment,A new organ failure in the first week, defined as the number and the severity of organ dysfunction 1 week after randomization Number of event ,Organ failure-free day on day 28 after randomization free day ,Renal replacement therapy-free day on day 28 after randomization free day ,28-day mortality after randomization 28 day after randomization mortality,Length of Intensive Care Unit stay after Intensive Care Unit discharge or death day,Vasopressor-free day on day 28 after randomization free day ,Ventilator-free day on day 28 after randomization free day ,Cumulative calcium administration (72 hours after randomization) Cumulative calcium in ml, mEq | — |
Countries
Thailand
Contacts
Public ContactSupawat Wittayapairoj
Faculty of Medicine, Khon Kaen University
Outcome results
None listed