Author:
García Alberto F.,Manzano-Nunez Ramiro,Carrillo Diana Cristina,Chica-Yanten Julian,Naranjo María Paula,Sánchez Álvaro I.,Mejía Jorge Humberto,Ospina-Tascón Gustavo Adolfo,Ordoñez Carlos A.,Bayona Juan Gabriel,Puyana Juan Carlos
Abstract
Abstract
Background
Previous observational studies showed higher rates of abdominal wall closure with the use of hypertonic saline in trauma patients with abdominal injuries. However, no randomized controlled trials have been performed on this matter. This double-blind randomized clinical trial assessed the effect of 3% hypertonic saline (HS) solution on primary fascial closure and the timing of abdominal wall closure among patients who underwent damage control laparotomy for bleeding control.
Methods
Double-blind randomized clinical trial. Patients with abdominal injuries requiring damage control laparotomy (DCL) were randomly allocated to receive a 72-h infusion (rate: 50 mL/h) of 3% HS or 0.9 N isotonic saline (NS) after the index DCL. The primary endpoint was the proportion of patients with abdominal wall closure in the first seven days after the index DCL.
Results
The study was suspended in the first interim analysis because of futility. A total of 52 patients were included. Of these, 27 and 25 were randomly allocated to NS and HS, respectively. There were no significant differences in the rates of abdominal wall closure between groups (HS: 19 [79.2%] vs. NS: 17 [70.8%]; p = 0.71). In contrast, significantly higher hypernatremia rates were observed in the HS group (HS: 11 [44%] vs. NS: 1 [3.7%]; p < 0.001).
Conclusion
This double-blind randomized clinical trial showed no benefit of HS solution in primary fascial closure rates. Patients randomized to HS had higher sodium concentrations after the first day and were more likely to present hypernatremia. We do not recommend using HS in patients undergoing damage control laparotomy.
Trial registration The trial protocol was registered in clinicaltrials.gov (identifier: NCT02542241).
Publisher
Springer Science and Business Media LLC
Subject
Emergency Medicine,Surgery
Cited by
1 articles.
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