CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 59 enrolled
Drug / intervention
Normal Saline +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03054922
NCT03054922Phase 3Completed

Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables

Nationwide Children's Hospital·interventional·Posted Feb 16, 2017·Updated Mar 25, 2020

In Brief

A Phase 3 clinical trial evaluating Normal Saline, Lactated Ringer, and 1 other intervention for Anesthesia. Completed, enrolled 59 participants across 1 site.

Detailed Summary

During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 16, 2017
Enrollment StartFeb 23, 2017
Primary CompletionSep 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.4 years ago

Interventions

Normal Salinedrug

IV infusion of 0.9% NaCl throughout surgery.

Lactated Ringerdrug

IV infusion of lactated ringer throughout surgery.

Normosol-R Injdrug

IV infusion of Normosol throughout surgery.