Acute Kidney InjurySALTNCT02345486
Isotonic Solution Administration Logistical Testing
A study testing 0.9% sodium chloride and Physiologically balanced fluid in people with Acute Kidney Injury, run by Vanderbilt University at 1 site in United States.
Trial summary
The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- 0.9% sodium chloride and Physiologically balanced fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 974 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Admitted to the adult medical intensive care unit (MICU) at Vanderbilt University Medical Center
Who cannot join
- Age<18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37209
About this study
Official title: Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial
The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.
- Conditions
- Acute Kidney Injury
- Being tested
- 0.9% sodium chloride, Physiologically balanced fluid
- Keywords
- Pilot Projects, Plasmalyte A, Ringer's lactate, Sodium Chloride, Critical Care, Resuscitation"
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% sodium chlorideOther
Physiologically balanced fluidOther
Also called Lactated ringers or Plasmalyte-A
| Study group | Role | What they receive |
|---|---|---|
| 0.9% sodium chloride | Active comparator | Participants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission. Receives: Other: 0.9% sodium chloride |
| Physiologically balanced fluid | Active comparator | Participants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission. Receives: Other: Physiologically balanced fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Isotonic Crystalloid Which is 0.9% Saline
Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is 0.9% sodium chloride, censored at 30 days. The primary outcome was the proportion of intravenous isotonic crystalloid administered in the ICU that was saline. This was a continuous variable calculated for each patient as the volume of saline received divided by volume of saline received plus volume of balanced crystalloids received with a range from 0.0 (no saline received) to 1.0 (only saline received).
Measured: 30 days
Secondary outcomes (21)
Proportion of Isotonic Crystalloid Which is Physiologically Balanced
Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is either Lactated ringers or Plasmalyte-A, censored at 30 days.
Measured: 30 days
Total Intravenous Input
Total volume of intravenous fluid administration during admission to the intensive care unit, censored at 30 days
Measured: 30 days
Total Isotonic Crystalloid Input
Total volume of intravenous isotonic crystalloid administration during admission to the intensive care unit, censored at 30 days
Measured: 30 days
Total Intravenous Colloid Input
Total volume of intravenous colloid administration (excluding blood products) during admission to the intensive care unit, censored at 30 days
Measured: 30 days
Total Intravenous Blood Product Administration
Total volume of packed red blood cells, platelets, and fresh frozen plasma administered during admission to the intensive care unit, censored at 30 days
Measured: 30 days
Highest Serum Chloride Between Enrollment and Day 30
highest serum chloride (mmol/L) during admission to the intensive care unit, censored at 30 days
Measured: 30 days
Highest Serum Sodium Between Enrollment and Day 30
Highest serum sodium concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Measured: 30 days
Lowest Bicarbonate Concentration Between Enrollment and Day 30
Lowest serum bicarbonate concentration (mmol/L) during admission to the intensive care unit, censored at 30 days
Measured: 30 days
Number of Patients With MAKE30
Incidence of Major Adverse Kidney Events by 30 days -- a composite outcome defined as one or more of the following: death, new use of renal replacement therapy, or persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)
Measured: 30 days
In-hospital Mortality
Death prior to the earlier of hospital discharge or day 30
Measured: 30 days
New Use of Renal Replacement Therapy
Receipt of new renal replacement therapy after the first study day, censored at 30 days
Measured: 30 days
Persistent Renal Dysfunction
Persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)
Measured: 30 days
Number of Contraindications
Number of contraindications to assigned study fluid identified by providers, censored at 30 days
Measured: 30 days
Incidence of Hyperchloremia
Incidence of hyperchloremia defined as a serum chloride greater than or equal to 110 mmol/L
Measured: 30 days
Incidence of Severe Hypochloremia
Incidence of severe hypochloremia defined as a serum chloride less than 90mmol/L
Measured: 30 days
Increase in Serum Creatinine
Increase in serum creatinine during hospitalization, censored at 30 days Change from baseline to highest value, median (IQR), mg/dl
Measured: 30 days
Incidence of Acute Kidney Injury
Incidence of stage II or III acute kidney injury by Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury criteria, censored at 30 days
Measured: 30 days
Intensive Care Unit Free Days to Day 28
ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit before 28 days. If the patient is admitted to an intensive care unit service at day 28 or dies prior to day 28, ICU-free days will be 0.
Measured: 28 days
Ventilator-free Days (VFD) to Day 28
Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing. If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28. If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0.
Measured: 28 days
Dialysis-free Survival to Day 28
Dialysis free survival to day 28 will be defined as the number of days alive and without dialysis receipt to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after last receipt of dialysis and remains free of dialysis. If the patient is receiving dialysis at day 28 or dies prior to day 28, VFD will be 0.
Measured: 28 days
Peak Creatinine in the First 30 Days
Highest creatinine value in the first 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- None (open label)
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Rice, Vanderbilt University
- Investigators
- Todd W Rice, M.D., M.Sc., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345486
- Sponsor's protocol ID
- 141349
- Acronym
- SALT
- Status last verified
- Oct 2019
- First submitted
- 19 Jan 2015
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.
PubMed 21705897Yunos 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 23073953Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
PubMed 24674927Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, Wang L, Byrne DW, Shaw AD, Bernard GR, Rice TW; SALT Investigators * and the Pragmatic Critical Care Research Group; SALT Investigators. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1362-1372. doi: 10.1164/rccm.201607-1345OC.
PubMed 27749094
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial
- ClinicalTrials.gov ID
- NCT02345486
- Acronym / sponsor ID
- SALT / 141349
- Conditions
- Acute Kidney Injury
- Keywords
- Pilot Projects, Plasmalyte A, Ringer's lactate, Sodium Chloride, Critical Care, Resuscitation"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 25 Oct 2019
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 crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9% sodium chloride | Active comparator | Other: 0.9% sodium chlorideParticipants in the '0.9% sodium chloride' arm will receive 0.9% sodium chloride ('normal saline') any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission. |
| Physiologically balanced fluid | Active comparator | Other: Physiologically balanced fluidParticipants in the 'physiologically balanced fluid' arm will receive physiologically balanced fluid (Lactated ringers or Plasmalyte-A) any time an isotonic crystalloid is ordered by a provider during the intensive care unit admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted to the adult medical intensive care unit (MICU) at Vanderbilt University Medical Center
Key exclusion criteria (1 listed)
- Age<18 years old
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% sodium chloride | Other | 0.9% sodium chloride |
| Physiologically balanced fluidAlso: Lactated ringers or Plasmalyte-A | Other | Physiologically balanced fluid |
Primary outcome
Proportion of Isotonic Crystalloid Which is 0.9% Saline
Time frame: 30 days
Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is 0.9% sodium chloride, censored at 30 days. The primary outcome was the proportion of intravenous isotonic crystalloid administered in the ICU that was saline. This was a continuous variable calculated for each patient as the volume of saline received divided by volume of saline received plus volume of balanced crystalloids received with a range from 0.0 (no saline received) to 1.0 (only saline received).
21 secondary outcomes
Proportion of Isotonic Crystalloid Which is Physiologically Balanced
Time frame: 30 days
Total Intravenous Input
Time frame: 30 days
Total Isotonic Crystalloid Input
Time frame: 30 days
Total Intravenous Colloid Input
Time frame: 30 days
Total Intravenous Blood Product Administration
Time frame: 30 days
Highest Serum Chloride Between Enrollment and Day 30
Time frame: 30 days
Highest Serum Sodium Between Enrollment and Day 30
Time frame: 30 days
Lowest Bicarbonate Concentration Between Enrollment and Day 30
Time frame: 30 days
Number of Patients With MAKE30
Time frame: 30 days
In-hospital Mortality
Time frame: 30 days
New Use of Renal Replacement Therapy
Time frame: 30 days
Persistent Renal Dysfunction
Time frame: 30 days
Number of Contraindications
Time frame: 30 days
Incidence of Hyperchloremia
Time frame: 30 days
Incidence of Severe Hypochloremia
Time frame: 30 days
Increase in Serum Creatinine
Time frame: 30 days
Incidence of Acute Kidney Injury
Time frame: 30 days
Intensive Care Unit Free Days to Day 28
Time frame: 28 days
Ventilator-free Days (VFD) to Day 28
Time frame: 28 days
Dialysis-free Survival to Day 28
Time frame: 28 days
Peak Creatinine in the First 30 Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21705897Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.
- 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 24674927Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
- Derived from this study: PubMed 27749094Semler MW, Wanderer JP, Ehrenfeld JM, Stollings JL, Self WH, Siew ED, Wang L, Byrne DW, Shaw AD, Bernard GR, Rice TW; SALT Investigators * and the Pragmatic Critical Care Research Group; SALT Investigators. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1362-1372. doi: 10.1164/rccm.201607-1345OC.
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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.
Todd W Rice, M.D., M.Sc. principal investigator
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 0.9% sodium chloride and Physiologically balanced fluid in people with 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 1 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 13 Nov 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?
Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Isotonic Crystalloid Which is 0.9% Saline (time frame: 30 days). 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 NCT02345486, which also lists 4 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 13 Nov 2019.