Hemodynamics, fluids & transfusion

Balanced Solution Versus Normal Saline in Predicted Severe Acute Pancreatitis: A Stepped Wedge Cluster Randomized Trial

Ann SurgPublished Randomised controlled trial

Primary resultResult — go to the resultDifference −4.3 mmol/L 95% CI −5.6 to −3.0

Authors' conclusion

Among patients with pSAP, using BMES in preference to NS resulted in a significantly more physiological serum chloride level, which was associated with multiple clinical benefits

Study context

Population
Patients with predicted severe acute pancreatitis (APACHE II score ≥8 and C-reactive protein >150 mg/L) admitted within 72 hours of symptom onset
Participants
259 patients · 11 sites
Comparison
BMES vs normal saline (NS) for intravenous fluid
  • BMESn = 112
  • NSn = 147reference
Primary endpoint
Serum chloride concentration
Follow-up
Trial day 3
Methodological detailsmulticentre, stepped-wedge, cluster-randomised, one-way crossover
  • Multicentre
  • Stepped-wedge
  • Cluster-randomised
  • One-way crossover

Primary result

As reported in the abstract

Difference

−4.3 mmol/L

95% CI −5.6 to −3.0

P < 0.001

By group

BMES vs NS
difference −4.3 mmol/L (95% CI −5.6 to −3.0); P < 0.001

Secondary outcomes

Systemic inflammatory response syndrome · trial day 7

P = 0.024

Organ failure-free days · trial day 7

P < 0.001

Days alive and out of ICU · trial day 30

P = 0.009

Days alive and out of hospital · trial day 30

P < 0.001

Original publication

Balanced Solution Versus Normal Saline in Predicted Severe Acute Pancreatitis: A Stepped Wedge Cluster Randomized Trial. Ann Surg. Published 6 May 2024. doi:10.1097/sla.0000000000006319

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