Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients

NCT06370975 | Not Yet Recruiting Phase 1

• 1 other identifier: Fluid resuscitation in trauma
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Fluid Resuscitation

Outcome Measures

Primary Outcomes (1)

• Rate of lactate clearance following resuscitation with different solutions

  assess lactate clearance in traumatic patients after resuscitation with 3% hypertonic saline, ringer's lactated saline and 0.9% normal saline

  baseline

Study Arms (3)

3% hypertonic Saline

EXPERIMENTAL

Drug: 3% hypertonic Saline

Ringer's lactated solution

EXPERIMENTAL

Drug: Ringer's lactated solution

0.9% Normal saline

EXPERIMENTAL

Drug: 0.9% Normal saline

Interventions

3% hypertonic Saline 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

3% hypertonic Saline

Ringer's lactated solution 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

Ringer's lactated solution

0.9% Normal saline 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

0.9% Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with traumatic injury (e.g., blunt or penetrating trauma, road accidents and patients posted for emergency orthopedic and abdominal surgeries.
• \. Patients' ≥ 18 years old.

You may not qualify if:

• \. 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.
• \. Patients with comorbidities (e.g. pre-existing renal dysfunction, end-stage renal disease, sever liver dysfunction or cirrhosis and coagulopathy or bleeding disorders.
• \. Patients with serum electrolyte abnormalities who required inotropic support at the time of presentation.
• \. Patients who are pregnant or burns trauma. 6. Patients receiving concurrent treatment with hypertonic solutions for other conditions.
• \. Patients refused to participate or continuation in the study. 8. Deaths directly due to trauma were excluded from the study.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Saline Solution, Hypertonic; Ringer's Lactate; Saline Solution

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Central Study Contacts

Ahmed Hevzy Mohamed Ibrahem

CONTACT

01021097974; ahmedhevzy2771996@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 17, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04