Critical IllnessBASENCT03537898
Balanced Solutions and Plasma Electrolytes
A study testing Lactated Ringer's and Normosol in people with Critical Illness and Acidosis, Metabolic, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acidosis, Metabolic
- What is being tested?
- Lactated Ringer's and Normosol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,093 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 2 Mar 2019
- 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
- Patients admitted to the Medical ICU during the study period (Enrolled patients who are discharged from the hospital are eligible again if they are readmitted to the Medical ICU during the study period)
Who cannot join
- Age < 18 years old
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Balanced Solutions and Plasma Electrolytes in the Medical Intensive Care Unit
The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent prospective, randomized trials have shown improved patient outcomes with the use of balanced crystalloids compared to saline. There have not been large randomized studies comparing acetate buffered balanced crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive Care Unit admission and hospital discharge.
Read the detailed description
BASE is a pilot, cluster-randomized, multiple-crossover trial of lactated Ringer's versus Normosol-R pH 7.4 with regard to plasma bicarbonate concentration between intensive care unit admission and hospital discharge among all patients admitted to the medical intensive care unit. Between June 2018 and January 2019, all patients admitted to the medical intensive care unit at Vanderbilt University Medical Center who are 18 years or older will be enrolled. The study will occur in one-month blocks. The medical intensive care unit (MICU) will be randomized to an initial fluid group (lactated Ringer's or Normosol). The assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). The assigned study fluid will switch at the end of each month-long block such that half of hte months are assigned to lactated Ringer's and half of the months are assigned to Normosol-R pH 7.4. It is anticipated that around 2,000 patients will be enrolled from the medical ICU during the study period. The primary outcome analysis will be an intention-to-treat comparison of the primary outcome of bicarbonate concentration (mmol/L) between enrollment and 7 days after enrollment between the lactated Ringer's and Normosol-R groups using generalized estimating equations with a random effect for study period and accounting for repeated measures.
- Conditions
- Critical Illness, Acidosis, Metabolic
- Being tested
- Lactated Ringer's, Normosol
- Keywords
- balanced crystalloid, crystalloid, isotonic, acetate, non-acetate, lactated Ringer's, Normosol
- Medical subject headings
- Critical Illness, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer'sOther
Also called Ringer's lactate, Non-acetate buffered solution
Lactated Ringer's will be used whenever an isotonic crystalloid is ordered
NormosolOther
Also called Normosol-R, Normosol-R pH 7.4, Acetate buffered solution
Normosol-R pH 7.4 will be used whenever an isotonic crystalloid is ordered
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer's | Active comparator | Patients in a MICU block randomized to lactated Ringer's will receive lactated Ringer's whenever isotonic intravenous fluid administration is ordered by the treating provider. Receives: Other: Lactated Ringer's |
| Normosol | Active comparator | Patients in a MICU block randomized to Normosol will receive Normosol-R pH 7.4 whenever isotonic intravenous fluid administration is ordered by the treating provider. Receives: Other: Normosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Bicarbonate Concentration
The primary outcome is a repeated measures variable of plasma bicarbonate concentration (mmol/L) between ICU admission and 7 days.
Measured: Between ICU admission and Day 7
Secondary outcomes (24)
Plasma Bicarbonate Concentration < 20 mmol/L
Measured: Between ICU admission and Day 7
Lowest Plasma Bicarbonate Concentration
Measured: Between ICU admission and Day 7
Plasma Chloride Concentration > 110 mmol/L
Measured: Between ICU admission and Day 7
Plasma Chloride Concentration < 100 mmol/L
Measured: Between ICU admission and Day 7
Highest Plasma Chloride Concentration
Measured: Between ICU admission and Day 7
Change in Plasma Chloride Concentration from Baseline to Peak
Measured: Between ICU admission and Day 7
Plasma Sodium Concentration > 145 mmol/L
Measured: Between ICU admission and Day 7
Plasma Sodium Concentration < 135 mmol/L
Measured: Between ICU admission and Day 7
Plasma Potassium Concentration > 5.5 mmol/L
Measured: Between ICU admission and Day 7
Plasma values for Sodium, Potassium, Chloride, Bicarbonate, Blood Urea Nitrogen, Creatinine, Calcium, and Lactate
Measured: Between ICU admission and Hospital Discharge or 30 Days
Strong Ion Difference
(Sodium + Potassium + Calcium) - (Chloride + Lactate) in mmol/L
Measured: Between ICU admission and Day 7
Arterial pH
Measured: Between ICU admission and Day 7
Arterial Standard Base Excess
Measured: Between ICU admission and Day 7
Major Adverse Kidney Events within 30 days
This composite outcome will be considered present if at least one of the following occur: (1) A patient dies prior to the earlier of hospital discharge or day 30; (2) A patient receives new renal replacement therapy between enrollment and day 30, or (3) A patient has persistent renal dysfunction at the earlier of hospital discharge or day 30 (persistent renal dysfunction is defined as ≥ 200% of creatinine from baseline)
Measured: 30 Days after Enrollment Censored at Hospital Discharge
30-Day In-Hospital Mortality
Measured: 30 Days after Enrollment Censored at Hospital Discharge
New Renal Replacement Therapy
The initiation of any renal replacement therapy between enrollment and 30 days censored at hospital discharge in a patient not known to have previously received renal replacement therapy.
Measured: 30 Days after Enrollment Censored at Hospital Discharge
Stage II or Higher Acute Kidney Injury
A patient will meet this outcome if they meet Kidney Disease Improving Global Outcomes (KDIGO) creatinine criteria for stage II acute kidney injury or higher
Measured: Between ICU admission and Day 7
Persistent Renal Dysfunction
Final creatinine value before discharge or 30 days after enrollment ≥ 200% of baseline creatinine.
Measured: 30 Days after Enrollment Censored at Hospital Discharge
Total Volume of Blood Product Transfusion
Measured: Between ICU admission and Day 7
Dose of Vasopressor
Dose of vasopressor (in norepinephrine equivalents, µg/kg/min)
Measured: Between ICU admission and Day 7
Intensive Care Unit-Free Days
Intensive care unit-free days to day 28 (ICU-free days) will be defined as the number of days from the time of the patient's physical transfer out of the ICU until day 28 after enrollment. Patients who die prior to day 28 after enrollment received a value of 0 for ICU-free days. Patients who never transfer out of the ICU prior to day 28 after enrollment will receive a value of 0 for ICU-free days. Patients who transferred out of the ICU, return to the ICU, and are not subsequently transferred out of the ICU again before day 28 after enrollment will receive a value of 0 for ICU-free days. For patients who transfer out of the ICU, are readmitted to the ICU, and subsequently transfer out of the ICU again prior to day 28 after enrollment, ICU-free days will be awarded based on the time of the final transfer out of the ICU prior to day 28 after enrollment.
Measured: Between ICU admission and Day 28
Vasopressor-Free Days
Vasopressor-free days to day 28 will be defined as the number of days from the time of vasopressor cessation until day 28 after enrollment. Patients who die prior to day 28 after enrollment will receive a value of 0 for vasopressor-free days. Patients who never cease to receive vasopressors prior to day 28 after enrollment receive a value of 0 for vasopressor-free days. Patients who achieve vasopressor cessation, return to receiving vasopressors, and do not again achieve vasopressor cessation before day 28 after enrollment receive a value of 0 for vasopressor-free days. For patients who achieve vasopressor cessation, return to receiving vasopressors, and subsequently achieve cessation of vasopressors again prior to day 28 after enrollment, vasopressor-free days will be awarded based on the time of the final cessation of vasopressors prior to day 28 after enrollment. Survivors who never receive vasopressors received 28 vasopressor-free days.
Measured: Between ICU admission and Day 28
Renal Replacement Therapy-Free Days
Renal replacement therapy-free days to day 28 (RRT- free days) will be defined as the number of days from the time of the final RRT treatment until day 28 after enrollment. Patients who die prior to day 28 after enrollment receive a value of 0 for RRT-free days. Patients who continue to receive RRT through day 28 after enrollment receive a value of 0 for RRT-free days. Patients who achieve RRT cessation, return to receiving RRT, and do not again achieve RRT cessation before day 28 after enrollment receive a value of 0 for RRT-free days. For patients who achieve RRT cessation, return to receiving RRT, and subsequently achieve cessation of RRT again prior to day 28 after enrollment, RRT-free days will be awarded based on the time of the final RRT treatment prior to day 28 after enrollment. Survivors who never receive RRT will be awarded 28 RRT-free days.
Measured: Between ICU admission and Day 28
Ventilator-Free Days
Ventilator-free days to day 28 (VFDs) will be defined as the number of days from the time of initiating unassisted breathing (breathing without support of the mechanical ventilator) until day 28 after enrollment. Patients who die prior to day 28 after enrollment will receive a value of 0 for VFDs. Patients who never achieve unassisted breathing prior to day 28 after enrollment will receive a value of 0 for VFDs. Patients who achieve unassisted breathing, returned to assisted breathing, and do not again achieve unassisted breathing before day 28 after enrollment will receive a value of 0 for VFDs. For patients who achieve unassisted breathing, return to assisted breathing, and subsequently achieve unassisted breathing again prior to day 28 after enrollment, VFDs will be awarded based on the time of the final initiation of unassisted breathing prior to day 28 after enrollment. Survivors who never experience assisted breathing will receive 28 VFDs.
Measured: Between ICU admission and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jun 2018
- Primary completion7 Feb 2019
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Semler, Vanderbilt University Medical Center
- Investigators
- Matthew W Semler, MD, MSc, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537898
- Sponsor's protocol ID
- 180397
- Acronym
- BASE
- Status last verified
- Oct 2019
- First submitted
- 14 May 2018
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 20950434Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
PubMed 29485925Self 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 29485926Weinberg L, Chiam E, Hooper J, Liskaser F, Hawkins AK, Massie D, Ellis A, Tan CO, Story D, Bellomo R. Plasma-Lyte 148 vs. Hartmann's solution for cardiopulmonary bypass pump prime: a prospective double-blind randomized trial. Perfusion. 2018 May;33(4):310-319. doi: 10.1177/0267659117742479. Epub 2017 Nov 16.
PubMed 29144182Weinberg L, Pearce B, Sullivan R, Siu L, Scurrah N, Tan C, Backstrom M, Nikfarjam M, McNicol L, Story D, Christophi C, Bellomo R. The effects of plasmalyte-148 vs. Hartmann's solution during major liver resection: a multicentre, double-blind, randomized controlled trial. Minerva Anestesiol. 2015 Dec;81(12):1288-97. Epub 2014 Nov 19.
PubMed 25407026Shin WJ, Kim YK, Bang JY, Cho SK, Han SM, Hwang GS. Lactate and liver function tests after living donor right hepatectomy: a comparison of solutions with and without lactate. Acta Anaesthesiol Scand. 2011 May;55(5):558-64. doi: 10.1111/j.1399-6576.2011.02398.x. Epub 2011 Feb 22.
PubMed 21342149Hadimioglu N, Saadawy I, Saglam T, Ertug Z, Dinckan A. The effect of different crystalloid solutions on acid-base balance and early kidney function after kidney transplantation. Anesth Analg. 2008 Jul;107(1):264-9. doi: 10.1213/ane.0b013e3181732d64.
PubMed 18635497Hasman H, Cinar O, Uzun A, Cevik E, Jay L, Comert B. A randomized clinical trial comparing the effect of rapidly infused crystalloids on acid-base status in dehydrated patients in the emergency department. Int J Med Sci. 2012;9(1):59-64. doi: 10.7150/ijms.9.59. Epub 2011 Nov 23.
PubMed 22211091Qian ET, Brown RM, Jackson KE, Wang L, Stollings JL, Freundlich RE, Wanderer JP, Siew ED, Bernard GR, Self WH, Casey JD, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial. Chest. 2025 Aug;168(2):336-345. doi: 10.1016/j.chest.2025.02.008. Epub 2025 Feb 17.
PubMed 39971001
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Solutions and Plasma Electrolytes in the Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03537898
- Acronym / sponsor ID
- BASE / 180397
- Conditions
- Critical Illness, Acidosis, Metabolic
- Keywords
- balanced crystalloid, crystalloid, isotonic, acetate, non-acetate, lactated Ringer's, Normosol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,093 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 25 May 2018 (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 administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent prospective, randomized trials have shown improved patient outcomes with the use of balanced crystalloids compared to saline. There have not been large randomized studies comparing acetate buffered balanced crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive Care Unit admission and hospital discharge.
Detailed description
BASE is a pilot, cluster-randomized, multiple-crossover trial of lactated Ringer's versus Normosol-R pH 7.4 with regard to plasma bicarbonate concentration between intensive care unit admission and hospital discharge among all patients admitted to the medical intensive care unit. Between June 2018 and January 2019, all patients admitted to the medical intensive care unit at Vanderbilt University Medical Center who are 18 years or older will be enrolled. The study will occur in one-month blocks. The medical intensive care unit (MICU) will be randomized to an initial fluid group (lactated Ringer's or Normosol). The assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). The assigned study fluid will switch at the end of each month-long block such that half of hte months are assigned to lactated Ringer's and half of the months are assigned to Normosol-R pH 7.4. It is anticipated that around 2,000 patients will be enrolled from the medical ICU during the study period. The primary outcome analysis will be an intention-to-treat comparison of the primary outcome of bicarbonate concentration (mmol/L) between enrollment and 7 days after enrollment between the lactated Ringer's and Normosol-R groups using generalized estimating equations with a random effect for study period and accounting for repeated measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer's | Active comparator | Other: Lactated Ringer'sPatients in a MICU block randomized to lactated Ringer's will receive lactated Ringer's whenever isotonic intravenous fluid administration is ordered by the treating provider. |
| Normosol | Active comparator | Other: NormosolPatients in a MICU block randomized to Normosol will receive Normosol-R pH 7.4 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 (1 listed)
- Patients admitted to the Medical ICU during the study period (Enrolled patients who are discharged from the hospital are eligible again if they are readmitted to the Medical ICU during the study period)
Key exclusion criteria (2 listed)
- Age < 18 years old
- Prisoners
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 |
|---|---|---|
| Lactated Ringer'sAlso: Ringer's lactate, Non-acetate buffered solutionLactated Ringer's will be used whenever an isotonic crystalloid is ordered | Other | Lactated Ringer's |
| NormosolAlso: Normosol-R, Normosol-R pH 7.4, Acetate buffered solutionNormosol-R pH 7.4 will be used whenever an isotonic crystalloid is ordered | Other | Normosol |
Primary outcome
Plasma Bicarbonate Concentration
Time frame: Between ICU admission and Day 7
The primary outcome is a repeated measures variable of plasma bicarbonate concentration (mmol/L) between ICU admission and 7 days.
24 secondary outcomes
Plasma Bicarbonate Concentration < 20 mmol/L
Time frame: Between ICU admission and Day 7
Lowest Plasma Bicarbonate Concentration
Time frame: Between ICU admission and Day 7
Plasma Chloride Concentration > 110 mmol/L
Time frame: Between ICU admission and Day 7
Plasma Chloride Concentration < 100 mmol/L
Time frame: Between ICU admission and Day 7
Highest Plasma Chloride Concentration
Time frame: Between ICU admission and Day 7
Change in Plasma Chloride Concentration from Baseline to Peak
Time frame: Between ICU admission and Day 7
Plasma Sodium Concentration > 145 mmol/L
Time frame: Between ICU admission and Day 7
Plasma Sodium Concentration < 135 mmol/L
Time frame: Between ICU admission and Day 7
Plasma Potassium Concentration > 5.5 mmol/L
Time frame: Between ICU admission and Day 7
Plasma values for Sodium, Potassium, Chloride, Bicarbonate, Blood Urea Nitrogen, Creatinine, Calcium, and Lactate
Time frame: Between ICU admission and Hospital Discharge or 30 Days
Strong Ion Difference
Time frame: Between ICU admission and Day 7
Arterial pH
Time frame: Between ICU admission and Day 7
Arterial Standard Base Excess
Time frame: Between ICU admission and Day 7
Major Adverse Kidney Events within 30 days
Time frame: 30 Days after Enrollment Censored at Hospital Discharge
30-Day In-Hospital Mortality
Time frame: 30 Days after Enrollment Censored at Hospital Discharge
New Renal Replacement Therapy
Time frame: 30 Days after Enrollment Censored at Hospital Discharge
Stage II or Higher Acute Kidney Injury
Time frame: Between ICU admission and Day 7
Persistent Renal Dysfunction
Time frame: 30 Days after Enrollment Censored at Hospital Discharge
Total Volume of Blood Product Transfusion
Time frame: Between ICU admission and Day 7
Dose of Vasopressor
Time frame: Between ICU admission and Day 7
Intensive Care Unit-Free Days
Time frame: Between ICU admission and Day 28
Vasopressor-Free Days
Time frame: Between ICU admission and Day 28
Renal Replacement Therapy-Free Days
Time frame: Between ICU admission and Day 28
Ventilator-Free Days
Time frame: Between ICU admission and Day 28
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 11 Oct 2019.
- 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 29485925Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
- Background: 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.
- Background: PubMed 29144182Weinberg L, Chiam E, Hooper J, Liskaser F, Hawkins AK, Massie D, Ellis A, Tan CO, Story D, Bellomo R. Plasma-Lyte 148 vs. Hartmann's solution for cardiopulmonary bypass pump prime: a prospective double-blind randomized trial. Perfusion. 2018 May;33(4):310-319. doi: 10.1177/0267659117742479. Epub 2017 Nov 16.
- Background: PubMed 25407026Weinberg L, Pearce B, Sullivan R, Siu L, Scurrah N, Tan C, Backstrom M, Nikfarjam M, McNicol L, Story D, Christophi C, Bellomo R. The effects of plasmalyte-148 vs. Hartmann's solution during major liver resection: a multicentre, double-blind, randomized controlled trial. Minerva Anestesiol. 2015 Dec;81(12):1288-97. Epub 2014 Nov 19.
- Background: PubMed 21342149Shin WJ, Kim YK, Bang JY, Cho SK, Han SM, Hwang GS. Lactate and liver function tests after living donor right hepatectomy: a comparison of solutions with and without lactate. Acta Anaesthesiol Scand. 2011 May;55(5):558-64. doi: 10.1111/j.1399-6576.2011.02398.x. Epub 2011 Feb 22.
- Background: PubMed 18635497Hadimioglu N, Saadawy I, Saglam T, Ertug Z, Dinckan A. The effect of different crystalloid solutions on acid-base balance and early kidney function after kidney transplantation. Anesth Analg. 2008 Jul;107(1):264-9. doi: 10.1213/ane.0b013e3181732d64.
- Background: PubMed 22211091Hasman H, Cinar O, Uzun A, Cevik E, Jay L, Comert B. A randomized clinical trial comparing the effect of rapidly infused crystalloids on acid-base status in dehydrated patients in the emergency department. Int J Med Sci. 2012;9(1):59-64. doi: 10.7150/ijms.9.59. Epub 2011 Nov 23.
- Derived from this study: PubMed 39971001Qian ET, Brown RM, Jackson KE, Wang L, Stollings JL, Freundlich RE, Wanderer JP, Siew ED, Bernard GR, Self WH, Casey JD, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial. Chest. 2025 Aug;168(2):336-345. doi: 10.1016/j.chest.2025.02.008. Epub 2025 Feb 17.
- Individual participant dataSharing planned: No
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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.
Matthew W Semler, MD, MSc study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactated Ringer's and Normosol in people with Critical Illness and Acidosis, Metabolic, run by Vanderbilt University Medical Center 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 1 inclusion and 2 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 11 Oct 2019. 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?
Plasma Bicarbonate Concentration (time frame: Between ICU admission and Day 7). 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 NCT03537898, which also lists 9 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 11 Oct 2019.