Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis. This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.

Official Title
-----------------
Development of Hypernatremia in Critically Ill Patients: Prospective Analysis

Conditions
-----------------
Hypernatremia, Critical Illness

Intervention / Treatment
-----------------
* Other: Daily urine collection for biochemical analysis
* Other: Subanalysis for comparison of 24hour urine collection versus spot-check measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to Intensive Care Unit Age 18 years or older Exclusion Criteria: Age 17 years or younger

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Daily urine collection for biochemical analysis|For every patient in ICU, a daily morning urine sample will be collected from the already collected urine via catheter.|
|Other: Subanalysis for comparison of 24hour urine collection versus spot-check measurements|For a subgroup of 30 sedated patients, 24 hour urine collection will be collected. In addition, every 2 hours a 10ml urine sample will be collected.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypernatremia | After one year of collecting data on fluid and sodium balances, the patients who developed hypernatremia during their admission in the Intensive Care Unit will be compared to the patients who remained normonatremic throughout their ICU admission. | During admission in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour urine replacement for spot-checks | Assessing whether 24 hour urine collection can be replaced by spot-check measurements of urine by comparing both 24 hour urine and 2 hourly urine samples | 24 hours |