Wounds and InjuriesNCT01270854
Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
A study testing Plasmalyte A and Normal Saline in people with Wounds and Injuries and Multiple Trauma, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an intravenous salt solution called "Plasmalyte" causes less abnormality of the body's acid levels than a solution called "Normal Saline." Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Multiple Trauma, Disorder of Fluid Balance
- What is being tested?
- Plasmalyte A and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2012
- Phase
- Interventional
- 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
- Triaged upon arrival to the hospital as severely injured
- At least 18 years of age
- Meets at least one of the following criteria:
- Intubated or likely to become intubated within 60 minutes of arrival at the hospital
- Likely to need an operation within 60 minutes of arrival
- Received or likely to receive a blood transfusion within 60 minutes of arrival
Who cannot join
- Greater than 60 minutes since arrival at the hospital
- Death likely within 48 hours
- Transfer from another hospital
- Pre-existing renal failure requiring dialysis
- Pregnancy
- Prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Medical Center
Sacramento, California, 95817
About this study
The purpose of this study is to determine whether an intravenous salt solution called "Plasmalyte" causes less abnormality of the body's acid levels than a solution called "Normal Saline."
Read the detailed description
Electrolyte-containing intravenous fluids are routinely administered to patients in the first few hours after acute traumatic injury. Although Normal Saline (0.9% sodium chloride) is commonly used in this setting, it causes a hyperchloremic acidosis that may exacerbate metabolic derangements that occur after acute injury. Plasmalyte A is a solution that more closely matches physiologic electrolyte levels. In this study, we will evaluate whether Plasmalyte A results in less disturbance of the base deficit 24 hours following traumatic injury than does Normal Saline.
- Being tested
- Plasmalyte A, Normal Saline
- Keywords
- Normal saline, Plasmalyte, Intravenous fluid, Traumatic injury, Fluid resuscitation
- Medical subject headings
- Wounds and Injuries, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmalyte AOther
Intravenous fluid
Normal SalineOther
Intravenous fluid
| Study group | Role | What they receive |
|---|---|---|
| Plasmalyte | Experimental | Administration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital Receives: Other: Plasmalyte A |
| Normal Saline | Active comparator | Administration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the base deficit
Base deficit at 24 hours after randomization minus the base deficit at randomization
Measured: 24 hours after randomization
Secondary outcomes (1)
Mortality
Measured: Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Garth H. Utter, MD, Study director, University of California, DavisLynette A. Scherer, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270854
- Sponsor's protocol ID
- 200917793
- Status last verified
- May 2017
- First submitted
- 3 Jan 2011
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Young JB, Utter GH, Schermer CR, Galante JM, Phan HH, Yang Y, Anderson BA, Scherer LA. Saline versus Plasma-Lyte A in initial resuscitation of trauma patients: a randomized trial. Ann Surg. 2014 Feb;259(2):255-62. doi: 10.1097/SLA.0b013e318295feba.
PubMed 23732264
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
- ClinicalTrials.gov ID
- NCT01270854
- Acronym / sponsor ID
- 200917793
- Keywords
- Normal saline, Plasmalyte, Intravenous fluid, Traumatic injury, Fluid resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Jan 2011 (estimated)
- 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 purpose of this study is to determine whether an intravenous salt solution called "Plasmalyte" causes less abnormality of the body's acid levels than a solution called "Normal Saline."
Detailed description
Electrolyte-containing intravenous fluids are routinely administered to patients in the first few hours after acute traumatic injury. Although Normal Saline (0.9% sodium chloride) is commonly used in this setting, it causes a hyperchloremic acidosis that may exacerbate metabolic derangements that occur after acute injury. Plasmalyte A is a solution that more closely matches physiologic electrolyte levels. In this study, we will evaluate whether Plasmalyte A results in less disturbance of the base deficit 24 hours following traumatic injury than does Normal Saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasmalyte | Experimental | Other: Plasmalyte AAdministration of Plasmalyte A as the standard intravenous fluid during the first 24 hours after arrival to the hospital |
| Normal Saline | Active comparator | Other: Normal SalineAdministration of Normal Saline as the standard intravenous fluid during the first 24 hours after arrival to the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Triaged upon arrival to the hospital as severely injured
- At least 18 years of age
- Meets at least one of the following criteria:
Key exclusion criteria (6 listed)
- Greater than 60 minutes since arrival at the hospital
- Death likely within 48 hours
- Transfer from another hospital
- Pre-existing renal failure requiring dialysis
- Pregnancy
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 |
|---|---|---|
| Plasmalyte AIntravenous fluid | Other | Plasmalyte |
| Normal SalineIntravenous fluid | Other | Normal Saline |
Primary outcome
Change in the base deficit
Time frame: 24 hours after randomization
Base deficit at 24 hours after randomization minus the base deficit at randomization
1 secondary outcome
Mortality
Time frame: Hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 23732264Young JB, Utter GH, Schermer CR, Galante JM, Phan HH, Yang Y, Anderson BA, Scherer LA. Saline versus Plasma-Lyte A in initial resuscitation of trauma patients: a randomized trial. Ann Surg. 2014 Feb;259(2):255-62. doi: 10.1097/SLA.0b013e318295feba.
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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.
Garth H. Utter, MD study director
University of California, Davis
Lynette A. Scherer, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmalyte A and Normal Saline in people with Wounds and Injuries and Multiple Trauma, run by University of California, Davis at 1 site in United States.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the base deficit (time frame: 24 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270854, which also lists 1 linked publication.
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 30 May 2017.