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154 compared to 54 mmol per liter of sodium in intravenous maintenance fluid therapy for adult patients undergoing major thoracic surgery (TOPMAST): a single-center randomized controlled double-blind trial.
- Source :
-
Intensive care medicine [Intensive Care Med] 2019 Oct; Vol. 45 (10), pp. 1422-1432. Date of Electronic Publication: 2019 Oct 01. - Publication Year :
- 2019
-
Abstract
- Purpose: To determine the effects of the sodium content of maintenance fluid therapy on cumulative fluid balance and electrolyte disorders.<br />Methods: We performed a randomized controlled trial of adults undergoing major thoracic surgery, randomly assigned (1:1) to receive maintenance fluids containing 154 mmol/L (Na154) or 54 mmol/L (Na54) of sodium from the start of surgery until their discharge from the ICU, the occurrence of a serious adverse event or the third postoperative day at the latest. Investigators, caregivers and patients were blinded to the treatment. Primary outcome was cumulative fluid balance. Electrolyte disturbances were assessed as secondary endpoints, different adverse events and physiological markers as safety and exploratory endpoints.<br />Findings: We randomly assigned 70 patients; primary outcome data were available for 33 and 34 patients in the Na54 and Na154 treatment arms, respectively. Estimated cumulative fluid balance at 72 h was 1369 mL (95% CI 601-2137) more positive in the Na154 arm (p < 0.001), despite comparable non-study fluid sources. Hyponatremia < 135 mmol/L was encountered in four patients (11.8%) under Na54 compared to none under Na154 (p = 0.04), but there was no significantly more hyponatremia < 130 mmol/L (1 versus 0; p = 0.31). There was more hyperchloremia > 109 mmol/L under Na154 (24/35 patients, 68.6%) than under Na54 (4/34 patients, 11.8%) (p < 0.001). The treating clinicians discontinued the study due to clinical or radiographic fluid overload in six patients receiving Na154 compared to one patient under Na54 (excess risk 14.2%; 95% CI - 0.2-30.4%, p = 0.05).<br />Conclusions: In adult surgical patients, sodium-rich maintenance solutions were associated with a more positive cumulative fluid balance and hyperchloremia; hypotonic fluids were associated with mild and asymptomatic hyponatremia.
- Subjects :
- Administration, Intravenous
Aged
Belgium
Double-Blind Method
Female
Fluid Therapy methods
Fluid Therapy statistics & numerical data
Humans
Infusions, Intravenous methods
Infusions, Intravenous standards
Infusions, Intravenous statistics & numerical data
Male
Middle Aged
Sodium therapeutic use
Thoracic Surgical Procedures methods
Thoracic Surgical Procedures statistics & numerical data
Water-Electrolyte Imbalance complications
Water-Electrolyte Imbalance prevention & control
Fluid Therapy standards
Sodium administration & dosage
Thoracic Surgical Procedures standards
Treatment Outcome
Subjects
Details
- Language :
- English
- ISSN :
- 1432-1238
- Volume :
- 45
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Intensive care medicine
- Publication Type :
- Academic Journal
- Accession number :
- 31576437
- Full Text :
- https://doi.org/10.1007/s00134-019-05772-1