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Comparison · NCT02444988-sae

0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: serious adverse events. Trial comparisons, record NCT02444988-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02444988-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.0000000000000000001080.00145wilson
Risk in group 2000.0014wilson
Risk difference, group 1 minus group 20-0.00140.00145newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 10.9% Sodium Chloride (Saline)
Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered
02,646EG000
Group 2Balanced Crystalloid
Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered
02,735EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
NCT number
NCT02444988
Phases
NA
Conditions
Critical Illness, Acute Kidney Injury
Interventions
0.9% Saline, Physiologically-balanced isotonic crystalloid
Lead sponsor
Vanderbilt University
Results first posted
2019-11-25

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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