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Completed

NCT Number: NCT05808972

0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis

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.

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Key information

Conditions

Metabolic Ketoacidosis Acetonemia Acetonuria Acid-Base Imbalance Acidosis Diabetes Complications Diabetes Mellitus Diabetic Ketoacidosis Endocrine System Diseases Ketoacidemia Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ahlem Trifi

Tunis, 1007, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium chloride 0.9% (SC)

Drug

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.

Other names: Hydration solution

Ringer lactate (RL)

Drug

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.

Other names: Hydration solution

Primary outcomes

  1. Number of participants with composite endpoint achievement

    Time frame: 48 hours from inclusion

    composite endpoint (glycemia <11 mmol/l, bicarbonates >15 mmol/l or pH >7.30 and anion gap <16).

Secondary outcomes

  1. change in base excess to ≥ -3 meq/L

    Time frame: at 48 hours and at 24 hours from inclusion

    to ≥ -3 meq/L

  2. Number of participants with hyperchloremia

    Time frame: at 48 hours from inclusion

    chlore level > 105 mmol/L

  3. Total insulin dose received

    Time frame: through study completion, an average of 9 months

    insulin dose prescribed during treatment

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Official study title

0.9% Sodium Chloride Versus Ringer's Lactate in the Treatment of Severe Diabetic Ketoacidosis: a Randomized Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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