Critical IllnessSaLt-EDNCT02614040
Saline Against Lactated Ringers or Plasmalyte in the Emergency Department
A study testing 0.9% Saline and Physiologically-balanced isotonic crystalloid in people with Critical Illness and Acute Kidney Injury, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for intravenous fluid administration in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Kidney Injury
- What is being tested?
- 0.9% Saline and Physiologically-balanced isotonic crystalloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 30 Jun 2017
- 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
- Patient in the Vanderbilt Adult Emergency Department
- Felt by treating clinician to require intravenous isotonic crystalloid
- Felt by treating clinician to require inpatient hospital admission
Who cannot join
- 1. Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center Adult Emergency Department
Nashville, Tennessee, 37232
About this study
Official title: Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)
This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for intravenous fluid administration in the emergency department.
Read the detailed description
The administration of intravenous fluids is ubiquitous in the care of the acutely ill. Commonly available isotonic crystalloid solutions contain a broad spectrum of electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SaLt-ED will be a large, cluster-randomized trial enrolling adults requiring intravenous isotonic crystalloid administration and hospital admission from the Vanderbilt University Emergency Department from January 1st 2016 until April 30 2017. The primary endpoint will be hospital-free days to day 28.
- Conditions
- Critical Illness, Acute Kidney Injury
- Being tested
- 0.9% Saline, Physiologically-balanced isotonic crystalloid
- Keywords
- crystalloid, acute kidney injury
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% SalineOther
Also called Normal saline, 0.9% sodium chloride
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Physiologically-balanced isotonic crystalloidOther
Also called Lactated Ringers, Ringer's Lactate, Plasma-Lyte© A
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
| Study group | Role | What they receive |
|---|---|---|
| 0.9% Saline | Active comparator | Patients in a month randomized to physiologically-balanced isotonic fluid will receive 0.9% Saline whenever isotonic intravenous fluid administration is ordered by the treating provider. Receives: Other: 0.9% Saline |
| Physiologically-balanced | Active comparator | Patients in a month randomized to physiologically-balanced isotonic fluid will receive physiologically-balanced isotonic crystalloid (Plasma-Lyte© A or Lactated Ringer's) whenever isotonic intravenous fluid administration is ordered by the treating provider. Receives: Other: Physiologically-balanced isotonic crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-free days to day 28
The number of days alive and free of hospitalization in the first 28 days after study enrollment. Patients alive at the time of discharge will be presumed to be alive at 28 days. A patient who dies before hospital discharge will receive zero hospital-free days. A patient who remains in the hospital 28 days after enrollment will receive zero hospital-free days.
Measured: 28 days after enrollment
Secondary outcomes (13)
Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury
Proportion of patients with Stage II or greater acute kidney injury by KDIGO creatinine criteria (defined as rise in serum creatinine level of at least 2-fold, a serum creatinine level greater than or equal to 4.0 mg/dL with an acute increase of at least 0.5 mg/dL, or initiation of new renal replacement therapy).
Measured: 30 days after enrollment censored at hospital discharge
Major adverse kidney event by hospital discharge or day 30 (MAKE30)
At least one of: death, new renal replacement therapy, or persistent renal dysfunction at the time of hospital discharge (serum creatinine level ≥ 200% of baseline). Patients discharged prior to day 30 will be assumed not to develop this outcome between hospital discharge and day 30.
Measured: 30 days after enrollment
In-Hospital Mortality
Death before hospital discharge
Measured: 30 days or hospital discharge, whichever occurs first
Hospital length of stay
Duration of hospitalization
Measured: Hospital length of stay assessed 90 days after enrollment
ICU-free days to day 28
Days alive and free of the intensive care unit in the first 28 days. Patients discharged prior to day 28 will be assumed to not have ICU days between discharge and day 28.
Measured: 28 days
Ventilator-free days to day 28
Days alive and free of mechanical ventilation in the first 28 days. Patients discharged prior to day 28 will be assumed to not have any ventilator days between discharge and day 28.
Measured: 28 days
Vasopressor-free days
Days alive and free of vasopressor receipt in the first 28 days. Patients discharged prior to day 28 will be assumed to not have vasopressor days between discharge and day 28.
Measured: 28 days
Receipt of new renal replacement therapy
Receipt of any form of renal replacement therapy in the first 30 days after enrollment in a patient who had not received renal replacement therapy prior to enrollment
Measured: 30 days after enrollment or hospital discharge, whichever occurs first
Duration of new renal replacement therapy
Duration of renal replacement therapy in the first 30 days after enrollment in a patient who had not received renal replacement therapy prior to enrollment
Measured: 30 days after enrollment
Peak creatinine
Highest creatinine in the 28 days after enrollment or hospital discharge, whichever occurs first
Measured: 28 days after enrollment or hospital discharge, whichever occurs first
Change from baseline to peak creatinine
Change from baseline creatinine at enrollment to the highest creatinine before death or hospital discharge in the first 28 days
Measured: 28 days after enrollment or hospital discharge, whichever occurs first
Incidence of metabolic acidosis and alkalosis
Incidence of metabolic acidosis and alkalosis in the first 30 days after enrollment as defined by bicarbonate values outside of the laboratory normal range.
Measured: 30 days after enrollment or hospital discharge, whichever occurs first
Incidence of hyperchloremia and hypochloremia
Incidence of hyperchloremia and hypochloremia in the first 30 days after enrollment as defined by serum chloride values outside of the laboratory normal range.
Measured: 30 days after enrollment or hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley Self, Vanderbilt University
- Investigators
- Wesley Self, MD MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614040
- Sponsor's protocol ID
- 151769
- Acronym
- SaLt-ED
- Status last verified
- Sep 2017
- First submitted
- 18 Nov 2015
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D, Du B, McArthur C, Myburgh J; SAFE TRIPS Investigators. Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care. 2010;14(5):R185. doi: 10.1186/cc9293. Epub 2010 Oct 15.
PubMed 20950434Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
PubMed 23073953Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334.
PubMed 26444692Self WH, Evans CS, Jenkins CA, Brown RM, Casey JD, Collins SP, Coston TD, Felbinger M, Flemmons LN, Hellervik SM, Lindsell CJ, Liu D, McCoin NS, Niswender KD, Slovis CM, Stollings JL, Wang L, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Clinical Effects of Balanced Crystalloids vs Saline in Adults With Diabetic Ketoacidosis: A Subgroup Analysis of Cluster Randomized Clinical Trials. JAMA Netw Open. 2020 Nov 2;3(11):e2024596. doi: 10.1001/jamanetworkopen.2020.24596.
PubMed 33196806Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, Slovis CM, Lindsell CJ, Ehrenfeld JM, Siew ED, Shaw AD, Bernard GR, Rice TW; SALT-ED Investigators. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27.
PubMed 29485926Self WH, Semler MW, Wanderer JP, Ehrenfeld JM, Byrne DW, Wang L, Atchison L, Felbinger M, Jones ID, Russ S, Shaw AD, Bernard GR, Rice TW. Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial. Trials. 2017 Apr 13;18(1):178. doi: 10.1186/s13063-017-1923-6.
PubMed 28407811
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SaLt-ED)
- ClinicalTrials.gov ID
- NCT02614040
- Acronym / sponsor ID
- SaLt-ED / 151769
- Conditions
- Critical Illness, Acute Kidney Injury
- Keywords
- crystalloid, acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,000 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 25 Nov 2015 (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.
This study will be a cluster-randomized, single-center trial comparing 0.9% saline (normal saline) vs physiologically-balanced crystalloid fluids (Lactated Ringers or Plasmalyte A) for intravenous fluid administration in the emergency department.
Detailed description
The administration of intravenous fluids is ubiquitous in the care of the acutely ill. Commonly available isotonic crystalloid solutions contain a broad spectrum of electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SaLt-ED will be a large, cluster-randomized trial enrolling adults requiring intravenous isotonic crystalloid administration and hospital admission from the Vanderbilt University Emergency Department from January 1st 2016 until April 30 2017. The primary endpoint will be hospital-free days to day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9% Saline | Active comparator | Other: 0.9% SalinePatients in a month randomized to physiologically-balanced isotonic fluid will receive 0.9% Saline whenever isotonic intravenous fluid administration is ordered by the treating provider. |
| Physiologically-balanced | Active comparator | Other: Physiologically-balanced isotonic crystalloidPatients in a month randomized to physiologically-balanced isotonic fluid will receive physiologically-balanced isotonic crystalloid (Plasma-Lyte© A or Lactated Ringer's) whenever isotonic intravenous fluid administration is ordered by the treating provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient in the Vanderbilt Adult Emergency Department
- Felt by treating clinician to require intravenous isotonic crystalloid
- Felt by treating clinician to require inpatient hospital admission
Key exclusion criteria (1 listed)
- 1. Age < 18 years
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 |
|---|---|---|
| 0.9% SalineAlso: Normal saline, 0.9% sodium chloride0.9% Saline will be used whenever an isotonic crystalloid is ordered | Other | 0.9% Saline |
| Physiologically-balanced isotonic crystalloidAlso: Lactated Ringers, Ringer's Lactate, Plasma-Lyte© ALactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered | Other | Physiologically-balanced |
Primary outcome
Hospital-free days to day 28
Time frame: 28 days after enrollment
The number of days alive and free of hospitalization in the first 28 days after study enrollment. Patients alive at the time of discharge will be presumed to be alive at 28 days. A patient who dies before hospital discharge will receive zero hospital-free days. A patient who remains in the hospital 28 days after enrollment will receive zero hospital-free days.
13 secondary outcomes
Stage II or greater KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO) Acute Kidney Injury
Time frame: 30 days after enrollment censored at hospital discharge
Major adverse kidney event by hospital discharge or day 30 (MAKE30)
Time frame: 30 days after enrollment
In-Hospital Mortality
Time frame: 30 days or hospital discharge, whichever occurs first
Hospital length of stay
Time frame: Hospital length of stay assessed 90 days after enrollment
ICU-free days to day 28
Time frame: 28 days
Ventilator-free days to day 28
Time frame: 28 days
Vasopressor-free days
Time frame: 28 days
Receipt of new renal replacement therapy
Time frame: 30 days after enrollment or hospital discharge, whichever occurs first
Duration of new renal replacement therapy
Time frame: 30 days after enrollment
Peak creatinine
Time frame: 28 days after enrollment or hospital discharge, whichever occurs first
Change from baseline to peak creatinine
Time frame: 28 days after enrollment or hospital discharge, whichever occurs first
Incidence of metabolic acidosis and alkalosis
Time frame: 30 days after enrollment or hospital discharge, whichever occurs first
Incidence of hyperchloremia and hypochloremia
Time frame: 30 days after enrollment or hospital discharge, whichever occurs first
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 15 Sep 2017.
- Background: PubMed 20950434Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D, Du B, McArthur C, Myburgh J; SAFE TRIPS Investigators. Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care. 2010;14(5):R185. doi: 10.1186/cc9293. Epub 2010 Oct 15.
- Background: PubMed 23073953Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
- Background: PubMed 26444692Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334.
- Derived from this study: PubMed 33196806Self WH, Evans CS, Jenkins CA, Brown RM, Casey JD, Collins SP, Coston TD, Felbinger M, Flemmons LN, Hellervik SM, Lindsell CJ, Liu D, McCoin NS, Niswender KD, Slovis CM, Stollings JL, Wang L, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Clinical Effects of Balanced Crystalloids vs Saline in Adults With Diabetic Ketoacidosis: A Subgroup Analysis of Cluster Randomized Clinical Trials. JAMA Netw Open. 2020 Nov 2;3(11):e2024596. doi: 10.1001/jamanetworkopen.2020.24596.
- Derived from this study: PubMed 29485926Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, Slovis CM, Lindsell CJ, Ehrenfeld JM, Siew ED, Shaw AD, Bernard GR, Rice TW; SALT-ED Investigators. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27.
- Derived from this study: PubMed 28407811Self WH, Semler MW, Wanderer JP, Ehrenfeld JM, Byrne DW, Wang L, Atchison L, Felbinger M, Jones ID, Russ S, Shaw AD, Bernard GR, Rice TW. Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial. Trials. 2017 Apr 13;18(1):178. doi: 10.1186/s13063-017-1923-6.
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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.
Wesley Self, MD MPH principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% Saline and Physiologically-balanced isotonic crystalloid in people with Critical Illness and Acute Kidney Injury, run by Vanderbilt University 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 3 inclusion and 1 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 15 Sep 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?
Hospital-free days to day 28 (time frame: 28 days after enrollment). 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 NCT02614040, which also lists 6 linked publications.
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 15 Sep 2017.