Fluid ResuscitationPhase 1/2NCT06370975
Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients
A Phase 1/2 study testing 3% hypertonic Saline, Ringer's lactated solution and 0.9% Normal saline in people with Fluid Resuscitation, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Resuscitation
- What is being tested?
- 3% hypertonic Saline, Ringer's lactated solution and 0.9% Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of 3% Hypertonic Saline Resuscitation on Lactate and Its Comparison With Ringer's Lactated Solution and 0.9% Normal Saline in Traumatic Injury Patients: A Prospective Randomized Control Trial
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
Read the 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
- Being tested
- 3% hypertonic Saline, Ringer's lactated solution, 0.9% Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% hypertonic SalineDrug
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 solutionDrug
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 salineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 3% hypertonic Saline | Experimental | Not described Receives: Drug: 3% hypertonic Saline |
| Ringer's lactated solution | Experimental | Not described Receives: Drug: Ringer's lactated solution |
| 0.9% Normal saline | Experimental | Not described Receives: Drug: 0.9% Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Aug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResuscitationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hevzy Mohamed Ibrahem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370975
- Sponsor's protocol ID
- Fluid resuscitation in trauma
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3% Hypertonic Saline Resuscitation on Lactate and Its Comparison With Ringer's Lactated Solution and 0.9% Normal Saline in Traumatic Injury Patients: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06370975
- Acronym / sponsor ID
- Fluid resuscitation in trauma
- Conditions
- Fluid Resuscitation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% hypertonic Salinethe 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 | Drug | 3% hypertonic Saline |
| Ringer's lactated solutionthe 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 | Drug | Ringer's lactated solution |
| 0.9% Normal salinethe 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 | Drug | 0.9% Normal saline |
Primary outcome
Rate of lactate clearance following resuscitation with different solutions
Time frame: baseline
assess lactate clearance in traumatic patients after resuscitation with 3% hypertonic saline, ringer's lactated saline and 0.9% normal saline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 3% hypertonic Saline, Ringer's lactated solution and 0.9% Normal saline in people with Fluid Resuscitation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hevzy Mohamed Ibrahem (01021097974, ahmedhevzy2771996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of lactate clearance following resuscitation with different solutions (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.