Acetonemia, Acetonuria, Ketoacidemia, Metabolic Ketoacidosis
Conditions
Keywords
Severe diabetic ketoacidosis,, Sodium chloride 0.9%, Ringer lactate, Base excess
Brief summary
Severe diabetic ketoacidosis (DKA) is a potentially serious complication of diabetes mellitus. The treatment regimen is based on insulin and rehydration. The choice of rehydration solution is a question that remains open. We sought to compare the effect of sodium chloride 0.9% (SC) versus ringer lactate (RL) in the resolution of severe DKA as well as on the variation of electrolytes.
Detailed description
We design an open randomized trial in adult patients admitted to our ICU for severe DKA. The insulin therapy protocol was identical and the randomization concerned the rehydration solution either by SC or RL. The primary endpoint was resolution of DKA at H48 defined by a composite endpoint (glycemia \<11 mmol/l, bicarbonates \> 15 mmol/l or pH\>7.30 and anion gap \<16). The secondary endpoints were resolution of DKA at H24, change in base excess to ≥ -3 meq/L at 48 h and H24 and change in electrolytes, insulin requirements, length of stay and mortality. Blood gases, ionogram with chloride and lactate were performed at baseline, H6, H12, H24 and H48.
Interventions
DRUGSodium chloride 0.9% (SC)
This trial looks specifically at the type of hydratation liquid. The patients included will receive SC. The volume, frequency of fluid administration and other severe DKA therapies, such as insulin therapy and electrolytes, are prescribed similarly. The intervention will continue for 48 hours from admission to the ICU with a blood gas control (including base excess) + Blood glucose + ionogram (Na, K, chlorine) + lactates on admission (or H0), H6, H12, H24 and H48.
The intervention will continue for 48 hours from admission to the ICU with a blood gas control (including base excess) + Blood glucose + ionogram (Na, K, chlorine) + lactates on admission (or H0), H6, H12, H24 and H48.
Sponsors
Tunis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Independant groups included by randomisation
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- All patients aged 16 and over hospitalized in intensive care for severe ketoacidosis defined as arterial pH ≤ 7.25 (or serum bicarbonate ≤ 15 mmol/L) and blood glucose ≥ 14 mmol/L and need for ICU.
Exclusion criteria
* \< 16 Y
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with composite endpoint achievement | 48 hours from inclusion | composite endpoint (glycemia \<11 mmol/l, bicarbonates \>15 mmol/l or pH \>7.30 and anion gap \<16). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in base excess to ≥ -3 meq/L | at 48 hours and at 24 hours from inclusion | to ≥ -3 meq/L |
| Number of participants with hyperchloremia | at 48 hours from inclusion | chlore level \> 105 mmol/L |
| Total insulin dose received | through study completion, an average of 9 months | insulin dose prescribed during treatment |
Countries
Tunisia
Outcome results
None listed