Potassium gluconate

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No OECD guideline available with which to compare the study design. Study design should have consisted of a complete cross-over with washout period where each subject serves as their own control. Sufficient reporting of results.

Data source

Reference

Reference Type:

publication

Title:

POTASSIUM RELOAD DURING DIURETIC TREATMENTS WITH A GLUCONATE SYRUP

Author:

Francois G

Bibliographic source:

69:2127-2129

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

not applicable

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

For 6 months, the authors systematically recharged patients with potassium glyconate in syrup. All were subjected to a regime without hospital salt which on an average of 24 h contained 40 mEq of potassium, an average quantity established for one week, taking into account loss of nutrition due to cooking.

GLP compliance:

not specified

Remarks:

Not applicable

Test material

Test material information

Constituent 1

Reference substance name:

Potassium gluconate

EC Number:

206-074-2

EC Name:

Potassium gluconate

Cas Number:

299-27-4

Molecular formula:

C6H12O7.K

IUPAC Name:

potassium (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate

Details on test material:

- Name of test material (as cited in study report): Potassium gluconate syrup, potassium salt.

Method

Subjects:

- Number of subjects exposed: 10.
- Sex: Male and female (3 women; 6 men; 1 not specified).
- Age: 56 - 76 years of age (men); 43 - 70 years of age (women); 54 years of age (sex of the subject not specified).
- Known diseases: Patients suffering from cardiac insufficiency subjected to different saluretics.

Route of exposure:

other: Test substance was provided orally or via injection to vein (number of subjects per route not specified).

Reason of exposure:

intentional

Exposure assessment:

measured

Results and discussion

Clinical signs:

The test substance was remarkably tolerated. The patients never had digestive intolerance, which is appreciable for a potassium therapy applied per os. Moreover, the patients never had surcharge accidents, nor had any metabolic troubles at all. The doses varied between 3 to 6 soup spoons per day, which represents a potassium contribution of 28 to 56 mEq. The patients started the therapy several days after the start of diuretic treatment thus preventing an overload accident in the case of marked oliguria. The contribution must have been daily even when the diuretics were given in a discontinuous manner. The pursuit of the treatment was judged on the determination of urinary potassium. When the latter correspond to the ingesta, the potassium therapy must be interrupted at the same time as the diuretic. On the other hand, if the kaliuria is clearly lower than the intakes, it is necessary to continue the contribution of gluconate after the saluretic treatment is stopped until equilibration of the balance is achieved. The effectiveness of the gluconate was made evident by the last observations (9 and 10) which concern clinically evident hypokalemias, spectacularly improved after several days of treatment.