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Sodium Lactate Solution

Clinical trials investigating “Sodium Lactate Solution” are studying how it performs in patient care settings, mainly in acute pancreatitis and in other hospital use contexts that include lactated solutions. These trials look at safety, effectiveness, and key outcome measures in specific patient groups, with attention to trial phase and treatment response.

Table of contents

Trial overview

The trial data include three interventional studies, which means researchers are giving a treatment and measuring the results.[1][2][3] The studies are in different phases, including Phase 3 and Phase 1/2, so they are at different steps of development.[1][2][3]

Although the article topic is “Sodium Lactate Solution”, the source data also include a trial of lactated Ringer’s solution, which is a lactated fluid used in acute pancreatitis research.[2] The other trials in the source data study different treatments and conditions, including dialysis care in end-stage kidney disease and a gene therapy study in Duchenne muscular dystrophy.[1][3]

Acute pancreatitis study

The WATERLAND trial is a Phase 3, open-label, multicenter, randomized controlled trial in people with acute pancreatitis.[2] Open-label means both the study team and the participants know which treatment is given, and randomized means people are assigned by chance to a treatment group.[2]

This study compares normal saline with lactated Ringer’s solution for fluid resuscitation, which means giving fluid to help treat dehydration and support the body during illness.[2] The main goal is to see whether lactated Ringer’s solution changes the severity of acute pancreatitis and whether it is safe in this setting.[2]

The primary outcome is the rate of moderately severe to severe acute pancreatitis within 30 days after randomization.[2] The safety outcome includes fluid overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis, which are important hospital safety problems.[2]

End-stage kidney disease study

The ELIXIR study is a Phase 3 interventional trial in people with end-stage kidney disease.[1] It is designed to test the efficacy and safety of XyloCore compared with standard glucose-based peritoneal dialysis solutions.[1]

This study uses many comparison products, all given by intraperitoneal use, which means into the peritoneal cavity inside the abdomen for dialysis treatment.[1] The brief summary says the main aim is to show non-inferiority, meaning XyloCore should work at least not worse than the standard treatment by a set margin.[1]

The primary outcome is weekly Kt/V urea, measured at several visits.[1] This is a dialysis measure that shows how well waste is being removed from the blood over a week.[1]

Duchenne muscular dystrophy study

The third study is a Phase 1/2 interventional trial in boys with Duchenne muscular dystrophy who can still walk.[3] The study is described as having three parts, starting with dose finding, then a comparison with placebo, and finally a longer follow-up period.[3]

The main purpose in part 1 is to find a safe and tolerable dose with acceptable gene expression, which means the study looks for a dose that the body can handle and that produces the expected biological response.[3] In part 2, the trial compares the treatment with placebo to assess safety and effectiveness after one year.[3]

The primary outcome is NSAA change from baseline at week 52.[3] NSAA is a score used to measure physical function in Duchenne muscular dystrophy, so this outcome helps show whether movement ability changes over time.[3]

Endpoints and measures

The trial endpoints focus on whether treatments help, how safe they are, and how well they perform in the target disease.[1][2][3] A primary outcome is the main result the study is built to measure.[1][2][3]

  • In acute pancreatitis, the main outcome is whether the disease becomes moderately severe or severe within 30 days.[2]

  • In end-stage kidney disease, the main outcome is weekly Kt/V urea, which reflects dialysis effectiveness.[1]

  • In Duchenne muscular dystrophy, the main outcome is NSAA change at week 52, which reflects physical function over time.[3]

Patient groups and participation

The studies do not include the same type of patient, so participation depends on the condition being studied.[1][2][3] One study is for adults with acute pancreatitis, one is for people with end-stage kidney disease, and one is for boys with Duchenne muscular dystrophy who can still walk.[1][2][3]

The enrollment numbers in the source data are 175, 100, and 90 participants, showing that the studies are of different sizes.[1][2][3] This helps explain how much patient data each trial plans to collect.[1][2][3]

What the trial data show

These trial records show that research linked to “Sodium Lactate Solution” spans different clinical settings and different study goals.[1][2][3] Some studies focus on later-stage comparison of treatments, while others are earlier studies that first look at dose, safety, and first signs of benefit.[1][3]

The most important patient-centered questions in these trials are whether the treatment helps, whether it is safe, and whether it improves disease-specific measures.[1][2][3] That is the main research focus of the available source data.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2024-513562-19-00 Phase 3 End-Stage Kidney Disease Authorised 175
NCT05781243 Phase 3 Acute pancreatitis Completed 100
2023-505187-11-00 Phase 1/2 Duchenne Muscular Dystrophy Authorised 90

FAQ

  • What is being studied in clinical trials of Sodium Lactate Solution? The trials focus on how lactated solutions perform in real patient care, especially in acute pancreatitis resuscitation. They measure whether the treatment is effective and safe in the studied group.
  • Who can take part in these trials? Each trial has its own target group. In the data provided, one trial includes people with acute pancreatitis, while other trials study different conditions and treatment settings.
  • What phase are the trials? The trial data include Phase 3 studies and one Phase 1/2 study. Trial phase shows how advanced the research is, from early testing to larger studies that compare treatments.
  • What outcomes are measured in the trials? The trials measure outcomes such as severity of illness, safety problems, and treatment response. One study uses a kidney function measure called weekly Kt/V urea, and another checks the rate of moderately severe to severe acute pancreatitis.
  • Are these trials only for one disease? No. The provided trial data show different conditions, including acute pancreatitis, end-stage kidney disease, and Duchenne muscular dystrophy. The studies are not all about the same patient group or the same goal.

Ongoing Clinical Trials on Sodium Lactate Solution

  • Study on XyloCore and Drug Combination for Patients with End-Stage Kidney Disease Undergoing Peritoneal Dialysis

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark Germany Italy Spain Sweden

  • Study of Microdystrophin (GNT0004) Gene Therapy for Duchenne Muscular Dystrophy in Boys Who Can Walk

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Study Comparing Sodium Chloride and Lactated Ringer’s Solution for Patients with Acute Pancreatitis

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, works well, or both.
  • Interventional study: A trial where researchers give a treatment or compare treatments to see what happens.
  • Phase 1/2: An early stage of research that looks at safety, dosing, and first signs of benefit.
  • Phase 3: A later stage of research with more participants, often used to compare a treatment with standard care.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result a trial is designed to measure.
  • Non-inferiority: A study goal to show that one treatment is not worse than another by more than a set amount.
  • Randomized controlled trial: A study where people are assigned by chance to different treatment groups, which helps compare them fairly.
  • Acute pancreatitis: A sudden inflammation of the pancreas, which can cause severe illness.
  • End-stage kidney disease: Very advanced kidney failure, when the kidneys can no longer work well enough on their own.
  • Weekly Kt/V urea: A measure used in dialysis to show how well waste is being removed from the blood.
  • NSAA: A score used in Duchenne muscular dystrophy studies to measure physical ability over time.

References

  1. https://clinicaltrials.gov/study/2024-513562-19-00
  2. https://clinicaltrials.eu/trial/study-comparing-sodium-chloride-and-lactated-ringers-solution-for-patients-with-acute-pancreatitis/
  3. https://clinicaltrials.gov/study/2023-505187-11-00