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Sodium Gluconate

Clinical trials investigating Sodium Gluconate are studying how it may be used in different hospital settings. The trials focus on outcomes such as safety, fluid management, and recovery in critically ill adults, children with scoliosis, patients having breast reconstruction, and people after cardiac arrest.

Table of contents

Trial overview

The source data includes four interventional clinical trials, meaning researchers assign a treatment or fluid strategy and then compare results in patients.[1][2][3][4] These trials are all authorised and are in Phase 2 or Phase 3.[1][2][3][4] The studies focus on very different hospital situations, including critical illness, scoliosis surgery, breast reconstruction, and cardiac arrest recovery.[1][2][3][4]

Although the article topic is Sodium Gluconate, the trial records provided here describe broader treatment strategies and fluid products rather than a single simple disease study.[1][2][3][4] The main purpose of these studies is to see whether the chosen fluid or treatment approach improves patient outcomes in the target population.[1][2][3][4]

Critically ill adults in the CRUSADERS study

The trial with ID 2025-520744-14-00 is the CRUSADERS study, a Phase 3 trial in critically ill adult patients.[1] It plans to enroll 640 people and is designed to test whether reducing sodium chloride in fluid creep and maintenance fluids leads to better outcomes than using mainly isotonic solutions.[1]

Fluid creep means extra fluid that patients receive through the IV line beyond the main planned treatment fluid, and maintenance fluids are fluids given to help meet daily needs.[1] The study compares several IV fluid types, including sodium chloride 0.9%, sodium chloride 0.3% plus glucose 3.3%, glucose 5%, and PlasmaLyte A.[1] The main outcome is days alive and without life support at 90 days after ICU admission.[1]

The brief study summary says the researchers expect that lowering sodium chloride burden may improve mortality and reduce the need for respiratory and kidney support.[1] This makes the trial important for people in the intensive care unit who are at high risk of organ problems.[1]

Children and adolescents having scoliosis surgery

The trial with ID 2024-514857-31-00 is a double-blind, randomized Phase 2 study in children and adolescents with neuromuscular scoliosis or adolescent idiopathic scoliosis who are undergoing instrumented spinal fusion.[2] It plans to enroll 90 participants.[2]

Double-blind means that neither the patient nor the study team knows which treatment is being given during the trial.[2] The study compares Plasma-Lyte 148 with octaplasLG, and the main outcome is intraoperative blood loss, which is the amount of blood lost during surgery after the wound is closed.[2]

The brief summary says the goal is to measure whether octaplas infusion can reduce blood loss compared with PlasmaLyte in people having posterior spinal fusion for scoliosis.[2] This trial is focused on surgery support, not long-term disease treatment.[2]

Fluid management during DIEP breast reconstruction

The trial with ID 2023-506152-24-00 is a Phase 3 randomized controlled trial in patients having deep inferior epigastric perforator (DIEP) free flap breast reconstruction.[3] It specifically studies arterial hypotension, which means low blood pressure in an artery, during this operation.[3] The trial plans to enroll 82 participants.[3]

The study compares goal-directed fluid management using Plasma-Lyte 148 and norepinephrine.[3] Goal-directed fluid therapy means fluids are adjusted based on the patient’s needs during surgery rather than given in a fixed way.[3] The primary outcome is the total intraoperative fluid volume from anesthesia induction until skin closure.[3]

The brief summary says the study is looking at whether this fluid strategy changes perioperative fluid administration, which means fluid given around the time of surgery.[3] This trial is relevant for patients undergoing complex reconstructive surgery where blood pressure and fluid balance matter.[3]

After cardiac arrest and brain injury

The trial with ID NCT05004610 is a Phase 2 study in people with cardiac arrest, coma, post-cardiac arrest syndrome, and post-anoxic brain injury.[4] It plans to enroll 125 participants.[4]

The study compares PlasmaLyte A with sodium lactate infusion.[4] The brief summary says the researchers want to see whether hypertonic sodium lactate infusion can decrease brain injury after cardiac arrest in comatose survivors.[4] Hypertonic means a solution with a higher concentration of dissolved substances than body fluids.[4]

The main outcome is the peak blood level of neuron specific enolase (NSE) at 48 hours after return of spontaneous circulation.[4] NSE is a blood marker that can help show whether the brain has been injured.[4] This trial focuses on early brain injury after successful resuscitation.[4]

Main outcomes being measured

Each trial has a different primary outcome, because each one is trying to answer a different clinical question.[1][2][3][4] In the ICU trial, the main endpoint is days alive without life support at 90 days.[1] In the scoliosis surgery trial, it is blood loss during surgery.[2] In the breast reconstruction trial, it is total fluid volume during surgery.[3] In the cardiac arrest trial, it is the NSE peak level at 48 hours.[4]

These outcomes are practical measures that help researchers compare one treatment strategy with another.[1][2][3][4] Some outcomes focus on survival and recovery, while others focus on surgery-related blood loss or fluid use.[1][2][3][4]

Important patient terms

Authorized means the study has been approved to run.[1][2][3][4] Enrollment is the number of people the trial plans to include.[1][2][3][4] Randomized means people are assigned by chance to different study groups.[2][3] Interventional means the researchers actively give a treatment or fluid strategy instead of only observing care.[1][2][3][4]

The studies use hospital-based treatments and focus on short-term outcomes that matter during critical illness or surgery.[1][2][3][4] This makes them useful for understanding how different fluid or treatment strategies may affect recovery in serious medical settings.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2025-520744-14-00 Phase 3 Critically ill patients Authorised 640
2024-514857-31-00 Phase 2 Neuromuscular scoliosis, adolescent idiopathic scoliosis Authorised 90
2023-506152-24-00 Phase 3 Arterial hypotension during DIEP free flap breast reconstruction Authorised 82
NCT05004610 Phase 2 Post-anoxic brain injury, post cardiac arrest syndrome, coma, cardiac arrest Authorised 125

FAQ

  • What are clinical trials of Sodium Gluconate trying to find out? They are trying to see whether the studied treatment approach improves patient outcomes in hospital care. The trials measure things like organ support, blood loss, fluid use, and signs of brain injury.
  • Who can take part in these trials? The target groups include critically ill adults, children and adolescents with scoliosis, people having DIEP breast reconstruction, and comatose survivors after cardiac arrest. Each trial has its own entry rules.
  • What phases are the Sodium Gluconate trials in? The listed trials are in Phase 2 and Phase 3. This means they are testing treatment strategies in patients and measuring how well they work.
  • What conditions are being studied? The trials study critical illness, scoliosis surgery, arterial hypotension during breast reconstruction, and post-cardiac arrest brain injury. These are all hospital-based conditions.
  • What outcomes are being measured? The trials measure outcomes such as days alive without life support, blood loss during surgery, total fluid volume, and neuron specific enolase levels. These outcomes help show whether the treatment strategy may be helpful.

Ongoing Clinical Trials on Sodium Gluconate

  • Study on Reducing Sodium Chloride and Glucose in Fluids for Critically Ill Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Effects of Sodium Lactate and Electrolyte Solution in Comatose Patients After Cardiac Arrest

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on Human Plasma Protein vs. Crystalloid for Fluid Management in Children with Scoliosis Undergoing Spinal Fusion Surgery

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on Fluid Therapy and Noradrenaline for Low Blood Pressure in Breast Reconstruction Surgery Patients

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium

Glossary

  • Clinical trial: A research study in people that tests a treatment, care plan, or medical strategy.
  • Interventional study: A trial where researchers assign a treatment or care strategy and then measure the results.
  • Phase 2: An earlier stage of testing that looks at whether a treatment strategy seems to work and how safe it is in a smaller group.
  • Phase 3: A later stage of testing in a larger group to compare outcomes and confirm benefit.
  • Enrollment: The number of people planned to join a trial.
  • Primary outcome: The main result the trial is designed to measure.
  • Days alive and without life support: A measure of how many days a patient is alive and does not need life support treatment.
  • Life support: Medical treatment that helps keep a person alive when their organs are not working well.
  • Intraoperative blood loss: The amount of blood lost during surgery.
  • Neuron specific enolase: A blood test marker that can rise when the brain has been injured.

References

  1. https://clinicaltrials.gov/study/2025-520744-14-00
  2. https://clinicaltrials.gov/study/2024-514857-31-00
  3. https://clinicaltrials.gov/study/2023-506152-24-00
  4. https://clinicaltrials.eu/trial/study-on-the-effects-of-sodium-lactate-and-electrolyte-solution-in-comatose-patients-after-cardiac-arrest/