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Completed

NCT Number: NCT02172092

Fluid Kinetics in Patients With Diabetic Ketoacidosis

The purpose with the study is to follow the fluid shifts that occur during fluid resuscitation of patients with diabetic ketoacidosis.

In the study measurements of changes in blood and urine concentrations of Sodium and Chloride as well as blood hemoglobin are used to mathematically calculate changes in distribution volumes of these different endogenous markers.

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Key information

Conditions

Diabetes Acid-Base Imbalance Acidosis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrinnevi Hospital

Norrköping, Östergötland County, 60379, Sweden

About this study

Patients treated for diabetic ketoacidosis receive 1000 ml of Sodium Chloride during the first 30 minutes of treatment.

Before, during and after this infusion regular blood samples(and urine) are collected (0, 10, 20, 30, 35, 40, 45, 50, 60, 120, 180 and 300 minutes after infusion start).

B-Hemoglobin, P-Albumine, B-Glucose, P-Sodium, P-Potassium. P-Chlorides, U-Sodium, U-Chloride and U-Glucose. Hourly volume of urine is measured.

The 30 minute infusion can be used to calculate the urine extracellular volume. Thereafter during infusion of Ringers acetate changes in electrolytes in blood as well as urine volume and in the urine excreted electrolytes can be used to calculate the fluid shifts between the different fluid compartments.

Eventually 8 to 12 hours later a second infusion of SodiumChloride is as a control performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.

Exclusion criteria

  • unconscious patient

Treatment and study plan

SodiumChloride

Drug

Infusion of SodiumChloride, blood samples to calculate extracellular volume.

Primary outcomes

  1. Extracellular volume

    Time frame: 120 minutes

    Masse balance as well as dilution af Sodium and Chloride are used to calculate extracellular volume during an infusion of SodiumChloride. Urine Sodium and Chloride are also measured to register and correct the mass balance.

Secondary outcomes

  1. Distribution of strong and weak acids

    Time frame: 12 hours

    Blood gases are followed. With the Stuart/(Loob) concept it is determined to what degree ketones, lactate or electrolyte shifts influence the acidosis of the blood.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Vrinnevi Hospital

Registry information

Acronym: FDKA

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jun 24, 2014
Registry last updated
Dec 12, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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