Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients

NCT ID: NCT06370975

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-09-30

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.

Conditions

Fluid Resuscitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

3% hypertonic Saline

Group Type: EXPERIMENTAL

3% hypertonic Saline

Intervention Type: DRUG

the patients received 3% HS at the rate of 4 mL/kg for 30 minutes. the intervention period for the study ran for the first hour of treatment, and serial monitoring and lab tests were done during this period, measurement lactate levels will done at 0, 30, 60 mins and 24 hour, the ABG parameters were recorded 30 and 60 min after the completion of the calculated dose infused with fluids and serial monitoring of vital parameters was done at 0, 15, 30, and 60 mins. The lactate clearance was calculated as follows:

-hour lactate clearance (%) = (0-hour lactate - 1-hour lactate) / 0-hour lactate × 100

Ringer's lactated solution

Group Type: EXPERIMENTAL

Ringer's lactated solution

Intervention Type: DRUG

the patients received ringer's lactated solution at the rate of 20 ml/kg for 30 minute. the intervention period for the study ran for the first hour of treatment, and serial monitoring and lab tests were done during this period, measurement lactate levels will done at 0, 30, 60 mins and 24 hour, the ABG parameters were recorded 30 and 60 min after the completion of the calculated dose infused with fluids and serial monitoring of vital parameters was done at 0, 15, 30, and 60 mins. The lactate clearance was calculated as follows:

-hour lactate clearance (%) = (0-hour lactate - 1-hour lactate) / 0-hour lactate × 100

0.9% Normal saline

Group Type: EXPERIMENTAL

0.9% Normal saline

Intervention Type: DRUG

the patients received 0.9% Ns at the rate of 20 ml/kg for 30 minute. the intervention period for the study ran for the first hour of treatment, and serial monitoring and lab tests were done during this period, measurement lactate levels will done at 0, 30, 60 mins and 24 hour, the ABG parameters were recorded 30 and 60 min after the completion of the calculated dose infused with fluids and serial monitoring of vital parameters was done at 0, 15, 30, and 60 mins. The lactate clearance was calculated as follows:

-hour lactate clearance (%) = (0-hour lactate - 1-hour lactate) / 0-hour lactate × 100

Interventions

3% hypertonic Saline

the patients received 3% HS at the rate of 4 mL/kg for 30 minutes. the intervention period for the study ran for the first hour of treatment, and serial monitoring and lab tests were done during this period, measurement lactate levels will done at 0, 30, 60 mins and 24 hour, the ABG parameters were recorded 30 and 60 min after the completion of the calculated dose infused with fluids and serial monitoring of vital parameters was done at 0, 15, 30, and 60 mins. The lactate clearance was calculated as follows:

-hour lactate clearance (%) = (0-hour lactate - 1-hour lactate) / 0-hour lactate × 100

Intervention Type: DRUG

Ringer's lactated solution

the patients received ringer's lactated solution at the rate of 20 ml/kg for 30 minute. the intervention period for the study ran for the first hour of treatment, and serial monitoring and lab tests were done during this period, measurement lactate levels will done at 0, 30, 60 mins and 24 hour, the ABG parameters were recorded 30 and 60 min after the completion of the calculated dose infused with fluids and serial monitoring of vital parameters was done at 0, 15, 30, and 60 mins. The lactate clearance was calculated as follows:

-hour lactate clearance (%) = (0-hour lactate - 1-hour lactate) / 0-hour lactate × 100

Intervention Type: DRUG

0.9% Normal saline

the patients received 0.9% Ns at the rate of 20 ml/kg for 30 minute. the intervention period for the study ran for the first hour of treatment, and serial monitoring and lab tests were done during this period, measurement lactate levels will done at 0, 30, 60 mins and 24 hour, the ABG parameters were recorded 30 and 60 min after the completion of the calculated dose infused with fluids and serial monitoring of vital parameters was done at 0, 15, 30, and 60 mins. The lactate clearance was calculated as follows:

-hour lactate clearance (%) = (0-hour lactate - 1-hour lactate) / 0-hour lactate × 100

Intervention Type: DRUG

Eligibility Criteria

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.

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

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hevzy Mohamed Ibrahem

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Hevzy Mohamed Ibrahem

Role: CONTACT

ahmedhevzy2771996@gmail.com

01021097974

Other Identifiers

Fluid resuscitation in trauma

Identifier Type: -

Identifier Source: org_study_id