Table of Contents
- Overview of the trials
- Conditions being studied
- Trial designs, phases, and who can join
- Main outcomes being measured
- Study-by-study trial summary
- What patients should know about the research
Overview of the trials
The trial data shows that Sodium Lactate is being tested in several different hospital settings, not for one single disease.[1] The studies are mainly looking at whether Sodium Lactate can help with fluid treatment, recovery, or organ support in serious conditions.[1][2]
Most of the studies are interventional trials, which means researchers give a treatment and compare the results with another group.[1] The trials are mostly in Phase 2 or Phase 3, so they are testing early effectiveness, safety, or comparison with standard fluids in larger patient groups.[1]
Conditions being studied
Sodium Lactate is being studied in people with diabetic ketoacidosis, a serious diabetes emergency where acid builds up in the body.[2] It is also being studied in septic shock, which is a life-threatening condition caused by severe infection and poor blood flow.[4][6]
Other trials include patients after cardiac arrest, people with post-anoxic brain injury or coma, and patients with acute pancreatitis.[3][5] One study also focuses on severe hyponatremia, which means very low blood sodium, especially when there is a risk of sodium being corrected too quickly.[1]
There is also a trial in people recovering from hip and knee replacements, where the outcome is early walking after surgery.[7] Another pediatric study is in children with end-stage kidney disease, although that trial is not about Sodium Lactate.[8]
Trial designs, phases, and who can join
All of the Sodium Lactate studies in the source data are interventional and are either Phase 2 or Phase 3 trials.[1] Some are randomized controlled trials, meaning patients are assigned by chance to different treatment groups.[1][4][5]
In the diabetic ketoacidosis trial, 300 patients are planned, and the study compares Sodium Lactate with Sodium Chloride infusion in intensive care patients.[2] In the septic shock pilot study, 40 patients are planned, and the trial compares a Sodium Lactate bolus with 3% saline, with close monitoring of heart and blood pressure changes.[4]
The cardiac arrest study plans to include 125 comatose survivors after return of spontaneous circulation, which means the heart started beating again after arrest.[3] The acute pancreatitis study plans 720 participants, and the severe hyponatremia study plans 260 patients with low sodium and a risk of overcorrection.[5][1]
One surgical recovery study includes 222 people having hip or knee replacement surgery, and it measures whether they can safely walk 5 meters within 6 hours after surgery.[7] The pediatric kidney study includes 20 children, showing that the source data also includes a younger population in a different trial.[8]
Main outcomes being measured
The main outcome in the severe hyponatremia study is the proportion of patients with serum sodium overcorrection during the first 48 hours after randomization.[1] Overcorrection means sodium rises too fast, and the trial defines this by different limits depending on whether risk factors are present, such as alcohol abuse, malnutrition, low potassium, or high blood sugar.[1]
In the diabetic ketoacidosis study, the main outcome is whether ketoacidosis resolves enough for ICU discharge at 24 hours, using glucose, ketones, and blood pH or bicarbonate as the criteria.[2] In the cardiac arrest study, the main outcome is the peak level of neuron specific enolase at 48 hours after the heart restarts, which is a blood marker used to reflect brain injury.[3]
The septic shock pilot study measures changes in cardiac stroke work, which is a way to estimate how well the heart is pumping, using stroke volume and mean arterial pressure at the start, 30 minutes, and 60 minutes after infusion.[4] The acute pancreatitis study looks at whether the illness becomes moderately severe or severe, and it also tracks safety problems such as fluid overload, kidney injury, high potassium, high calcium, or acidosis.[5]
The septic shock outcome in the completed ANDROMEDA-SHOCK-2 study is a combined result that includes death within 28 days, time until vital support stops, and hospital stay length.[6] In the surgery study, the main outcome is simple and practical: whether the person can walk 5 meters safely and independently within 6 hours after surgery.[7]
Study-by-study trial summary
2023-507254-32-00 is a Phase 3, multicenter, open-label randomized controlled trial in severe hyponatremia with 260 planned participants.[1] It studies whether systematic DDAVP use lowers the chance of sodium overcorrection in the first 48 hours.[1]
2024-511513-37-00 is a Phase 3 trial in 300 patients with diabetic ketoacidosis.[2] It compares Sodium Lactate infusion with Sodium Chloride infusion and measures whether ketoacidosis resolves enough for ICU discharge at 24 hours.[2]
NCT05004610 is a Phase 2 study in 125 patients with cardiac arrest-related brain injury or coma after return of spontaneous circulation.[3] It tests hypertonic sodium lactate and measures neuron specific enolase at 48 hours as a marker of brain injury.[3]
2024-517927-37-00 is a Phase 2 pilot study in 40 patients with septic shock who need fluid resuscitation.[4] It compares Sodium Lactate with 3% saline and checks short-term changes in stroke volume and mean arterial pressure.[4]
2024-511229-79-00 is a Phase 3 multicenter randomized trial in 720 patients with acute pancreatitis.[5] It compares lactated Ringer’s solution with normal saline and looks at disease severity and safety problems.[5]
NCT05057611 is a completed Phase 3 trial in 500 septic shock patients.[6] It tested a capillary refill time-targeted resuscitation approach and measured a combined 28-day clinical outcome.[6]
2022-501221-21-00 is a completed Phase 3 trial in 222 people having hip or knee replacement surgery.[7] It studied early walking after surgery, and Sodium Lactate was one of the fluids listed in the intervention set.[7]
What patients should know about the research
These trials show that Sodium Lactate is being studied as part of hospital fluid care in urgent and serious conditions.[1][2][4][5]
The studies do not all measure the same thing, because each condition has a different main problem to solve, such as blood sodium control, acid balance, brain injury, blood flow, or recovery after surgery.[1][2][3][4][5][7]
Overall, the trial data suggests that researchers are still trying to learn where Sodium Lactate may fit best among hospital fluids and supportive treatments.[1][2][3][4][5][6]
