Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients

Phase 1

Not yet recruiting

• Conditions: Fluid Resuscitation
• Interventions: Drug: 3% hypertonic Saline; Drug: Ringer's lactated solution; Drug: 0.9% Normal saline

• Registration Number: NCT06370975
• Lead Sponsor: Assiut University

Brief Summary

The study aims to investigate the effect of 3% hypertonic saline resuscitation on lactate clearance in comparison to ringer's lactated solution and 0.9% normal saline in traumatic injury patients.

Also to provide insights into the optimal fluid resuscitation strategy for traumatic injury patients

Detailed Description

Traumatic injuries considered as important leading causes of morbidity and mortality worldwide; haemorrhagic shock is a common and critical complication. Fluid resuscitation is a crucial step in managing traumatic injury patients, and the choice of resuscitation fluid can significantly impact patient outcomes. In the context of trauma, rapid and effective resuscitation is essential to prevent irreversible cellular dysfunction and multi-organ failure.

Lactate is a key indicator of tissue perfusion and oxygenation in trauma patients, with faster clearance rates associated with improved outcomes. There is growing interest in the use of hypertonic saline for resuscitation in traumatic injury patients, as it may lead to faster lactate clearance compared to traditional crystalloid solutions such as ringer's lactated solution and 0.9% normal saline. Additionally, it has been suggested that hypertonic saline may improve microvascular blood flow and tissue oxygenation, which can aid in lactate clearance. Ringer's lactated solution is commonly used for fluid resuscitation in trauma patients, providing volume expansion and buffering capacity. Furthermore, 0.9% normal saline is widely utilized in clinical practice, but concerns regarding its potential to induce hyperchloremic acidosis have been raised. Given the varied physiological effects of these resuscitative fluids, it is imperative to conduct a robust randomized controlled trial to elucidate their respective impacts on lactate clearance and overall outcomes in traumatic injury patients. Such a comprehensive trial will facilitate evidence-based decision-making and potentially optimize resuscitation strategies in the acute care of trauma patients, ultimately improving survival and reducing the burden of trauma-related morbidity and mortality. To our knowledge there is few studies discussing the differences between the use of 3% hypertonic, ringer's lactated and 0.9% normal salines in urgent resuscitation of trauma patients.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-13
• Study First Submitted QC: 2024-04-13
• Last Update Submitted: 2024-04-13
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17
• Study Start: 2024-08-01
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients with traumatic injury (e.g., blunt or penetrating trauma, road accidents and patients posted for emergency orthopedic and abdominal surgeries.

2. Patients' ≥ 18 years old.

Exclusion Criteria

1. Patients with traumatic brain injury or spinal cord injury. 2. Patients with known hypersensitivity or allergy 3% hypertonic, ringer's lactated and 0.9% normal salines.

2. Patients with comorbidities (e.g. pre-existing renal dysfunction, end-stage renal disease, sever liver dysfunction or cirrhosis and coagulopathy or bleeding disorders.

3. Patients with serum electrolyte abnormalities who required inotropic support at the time of presentation.

4. Patients who are pregnant or burns trauma. 6. Patients receiving concurrent treatment with hypertonic solutions for other conditions.

5. Patients refused to participate or continuation in the study. 8. Deaths directly due to trauma were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% hypertonic Saline	3% hypertonic Saline	-
Ringer's lactated solution	Ringer's lactated solution	-
0.9% Normal saline	0.9% Normal saline	-

Primary Outcome Measures

Name	Time	Method
Rate of lactate clearance following resuscitation with different solutions	baseline	assess lactate clearance in traumatic patients after resuscitation with 3% hypertonic saline, ringer's lactated saline and 0.9% normal saline