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Table 6 Serious adverse events: clinical details

From: Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a phase II rehydration trial for severe dehydration: WHO plan C versus slow rehydration

Number Site Arm Event type Outcome Relationship* Additional details
GAS230 Mbale Plan C Convulsions Resolved Unlikely Lethargic at admission and suffered repeated seizures/status (controlled by IV diazepam) after admission leading to worsening conscious level. Previous history of seizures prior to admission (in this illness). Severe malaria anaemia: received 1 unit of whole blood.
GAS263 Mbale Slow Suspected Pulmonary oedema Fatal Unlikely Severe pneumonia and gastroenteritis. Left-sided pleural effusion on x-ray. Lethargic at admission. Had worsening difficulty in breathing needing supplemental oxygen. Died about 36 h into admission.
GAS002 Kilifi Plan C Cardiovascular collapse/heart failure Fatal Probable Comatose, hypoglycaemic and in shock at admission. Fluid boluses x 2: post-resuscitation echo showed “worsening biventricular function, tricuspid regurgitation and right atrial enlargement” treated with frusemide intravenously. Died 13 h into admission: cause of death: heart failure.
GAS003 Kilifi Plan C Cardiovascular collapse Fatal Unlikely Severe pneumonia and gastroenteritis and had prolonged capillary refilling and a weak pulse at admission. Required supplemental oxygen at admission but did get a bolus. Died 1-h post-admission following cardiovascular collapse. Blood culture: Haemophilus influenzae.
GAS004 Kilifi Slow Convulsions Resolved Unlikely Comatose and hypoglycaemic at admission. Suffered seizures on day 3 of admission. Admission history suggested seizures (in this illness) prior to admission. Seizures were controlled with I.V phenobarbitone
GAS007 Kilifi Slow Cardiovascular collapse Fatal Unlikely Comatose at admission, very sick needing supplemental oxygen (saturations 52%) by mask and had hepatomegaly 4 cm BCM. Suffered seizures following admission which were controlled with I.V phenytoin. Died about 10 h into admission following cardiac arrest that was preceded by respiratory arrest.
  1. *By attending clinician