In short
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.
Key points
- Clinical trials investigating Sodium Gluconate are being used in hospital research settings that involve very different patient groups. The studies include critically ill adults, children and adolescents having scoliosis surgery, patients having DIEP breast reconstruction, and comatose survivors after cardiac arrest. The trials are in Phase 2 and Phase 3, so they are looking at both early and later-stage treatment effects. Researchers are measuring outcomes such as days alive without life support, blood loss during surgery, total fluid volume, and brain injury markers. The main goal across these studies is to see whether the tested treatment strategies improve patient outcomes in serious medical situations.
Trial overview
The source data includes four interventional clinical trials, meaning researchers assign a treatment or fluid strategy and then compare results in patients. These trials are all authorised and are in Phase 2 or Phase 3. The studies focus on very different hospital situations, including critical illness, scoliosis surgery, breast reconstruction, and cardiac arrest recovery.
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. The main purpose of these studies is to see whether the chosen fluid or treatment approach improves patient outcomes in the target population.
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. 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.
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. 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. The main outcome is days alive and without life support at 90 days after ICU admission.
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. This makes the trial important for people in the intensive care unit who are at high risk of organ problems.
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. It plans to enroll 90 participants.
Double-blind means that neither the patient nor the study team knows which treatment is being given during the trial. 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.
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. This trial is focused on surgery support, not long-term disease treatment.
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. It specifically studies arterial hypotension, which means low blood pressure in an artery, during this operation. The trial plans to enroll 82 participants.
The study compares goal-directed fluid management using Plasma-Lyte 148 and norepinephrine. Goal-directed fluid therapy means fluids are adjusted based on the patient’s needs during surgery rather than given in a fixed way. The primary outcome is the total intraoperative fluid volume from anesthesia induction until skin closure.
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. This trial is relevant for patients undergoing complex reconstructive surgery where blood pressure and fluid balance matter.
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. It plans to enroll 125 participants.
The study compares PlasmaLyte A with sodium lactate infusion. The brief summary says the researchers want to see whether hypertonic sodium lactate infusion can decrease brain injury after cardiac arrest in comatose survivors. Hypertonic means a solution with a higher concentration of dissolved substances than body fluids.
The main outcome is the peak blood level of neuron specific enolase (NSE) at 48 hours after return of spontaneous circulation. NSE is a blood marker that can help show whether the brain has been injured. This trial focuses on early brain injury after successful resuscitation.
Main outcomes being measured
Each trial has a different primary outcome, because each one is trying to answer a different clinical question. In the ICU trial, the main endpoint is days alive without life support at 90 days. In the scoliosis surgery trial, it is blood loss during surgery. In the breast reconstruction trial, it is total fluid volume during surgery. In the cardiac arrest trial, it is the NSE peak level at 48 hours.
These outcomes are practical measures that help researchers compare one treatment strategy with another. Some outcomes focus on survival and recovery, while others focus on surgery-related blood loss or fluid use.
Important patient terms
Authorized means the study has been approved to run. Enrollment is the number of people the trial plans to include. Randomized means people are assigned by chance to different study groups. Interventional means the researchers actively give a treatment or fluid strategy instead of only observing care.
The studies use hospital-based treatments and focus on short-term outcomes that matter during critical illness or surgery. This makes them useful for understanding how different fluid or treatment strategies may affect recovery in serious medical settings.