Evaluating the Effect of Hypertonic Saline in Critically Ill Patients with Generalized Edema: A Randomized, Open-Label, Blinded Outcome Clinical Trial

Abstract

Background: It is known that in certain situations, such as heart failure, hypertonic saline can facilitate fluid removal by diuretics — especially loop diuretics — which improve the pathophysiological condition and reduce symptoms in hospitalized ICU patients. Objectives: Our study aimed to evaluate the effect of adding 5% NaCl solution to loop diuretics in managing edema and increasing urine volume in critically ill patients with edema. Methods: This study was designed as a two-arm, parallel-group, randomized, open-label clinical trial with blinded outcome assessment. Critically ill adult patients with 2+ edema or greater were included in the study and randomly allocated into two groups: Intervention and control. In the intervention group, patients received 20 mg of furosemide plus 50 mL of hypertonic saline; in the control group, patients received 20 mg of furosemide plus 50 mL of normal saline. Both were infused over 30 minutes, three times daily for 48 hours. Changes in urine output and edema were assessed. Results: Twenty-eight patients were recruited and randomly allocated into intervention and control arms, with 14 patients in each group. The two groups were similar in terms of baseline demographic and laboratory characteristics. Urine volume increased significantly in both groups at 24 and 48 hours after the intervention; however, there were no statistically significant differences in edema changes, total urine output, or changes in urine volume between the two groups at 24 and 48 hours post-enrollment. After the trial, the percentage of patients with 4+ edema in the intervention group decreased from 21.43% to 0%, and in the control group from 7.14% to 0%. Edema graded 1+ increased from 0% to 28.57% and 42.86% in the intervention and control groups, respectively. Additionally, urine output in the control group increased from 1,550 mL to 4,450 mL per day, and in the intervention group from 2,025 mL to 3,600 mL per day, 48 hours after the start of the study. Conclusions: The results showed that critically ill patients hospitalized in the intensive care unit (ICU) with edema respond well to diuretic therapy. However, adding hypertonic saline to loop diuretics does not demonstrate a synergistic effect in these patients. Further studies with a larger sample size or a higher dose of saline and diuretic are recommended.