Aim

To assess safety of faster fluid administration (6 hours rather than 12) in children with severe acute malnutrition(SAM) and severe dehydration. 

Rationale

SAM is unfortunately still common. These patients are vulnerable and get sick often and frequently present with dehydration. Not only is this dehydration difficult to assess clinically, they have excess body water/sodium and low potassium. Therefore WHO guidelines recommended slow intravenous hydration (if needed) over 12 hours to avoid heart failure. The authors are questioning if this caution is necessary 

Design

Single-centre unblinded randomised controlled trial.

Setting

international Centre for Diarrhoeal Disease Research in Dhaka, Bangladesh.

Population

Children 6-60 months with z-score <3 with or without pedal oedema and 3 or more watery stools in <24 hours .

Intervention

Intervention; 100mls/kg of balanced saline/bicarb fluid over 6 hours

Standard care; 15mls/kg over 2 hours followed by 5-10mls/kg of rice based ORS via NG

All patients received breast milk or supplemental milk, ORS for ongoing loses, 5 days of broad spectrum antibiotics, water to thirst, vit A, folic acid, zinc and multivitamins.

Primary outcome

Treatment failure; defined as signs of dehydration after 6 or 12 hours in each group.

Secondary outcomes

Early signs of fluid overload with >5% weight gain

Clinical signs of heart failure

Results

The two groups were comparable, 22-25 % had pedal oedema.

Percentage weight gain (a proxy for level of dehydration ) was 8.5-9%. 60% were positive for chlorea

None still had dehydration at end of period (6 or 12 hours) and similar numbers required rescue fluids/ORS (17/18%)

No patients developed heart failure

Author's Discussion

Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition

Strengths

Appropriate inclusion criteria

Pragmatic use of fluids and comparable groups. Pragmatic clinical definition of heart failure/fluid overload

High percentage had pedal oedema (feels about normal for this cohort of patients)

Under research area with high degree of follow up.

intervention is simpler to enact than standard control; save time and staff effort.

Weakness

Specialist centre decrease generalizability of result Primary outcome that used power calculation was based on was treatment failure, authors seem to generalise more about safety (which is the main concern from fast fluid) but this is unjustified based on design of the study. High percentage had a positive sample of cholera, significantly limiting generalizability.

My humble opinion

Reassuring that no patients developed heart failure in this cohort of 100 or so patients with severe malnutrition and severe dehydration who received 100mls/kg of fluid over 6 hours. However, this study was not designed to examine the safety of this approach. The narrow spectrum of this study; a single specialist centre with a high proportion of cholera cases limits the generalisability therefore I would still follow WHO guidelines and provide fluids slower. However, if faster fluids are clinically indicated in SAM patients this study would make me more confident to prescribe this but would still want to observe this patient very closely.