Journal club33333 use of isotonic saline as maintenance

Journal clubJournal clubYassin M. Al-saleh

Dr.Sumahya Al-hajjaj

Yassin M. Al-saleh Dr.Sumahya Al-hajjaj

بسم الله الرحمن الرحيم

�ل� • �ا م�ن� الم�اء� ك )و�ج�ع�لن)�ىء� ح�ى ش�

•And we made every living thing of water.

TitleTitle

November 2008 - Volume 9 - Issue 6

Objectives :Objectives :• primarily intend to

determine whether the use of isotonic fluids prevents hyponatremia.

• secondly, whether these fluids increase the incidence of adverse events.

IntroductionIntroduction• In 1956, scientists suggested that daily

electrolyte requirements might be similar to oral requirements.

• Children achieved adequate growth and natremia levels when fed with mother’s milk or an adapted formula.

• they assumed that 10- 30 meq/L sodium would be suitable for administration as an intravenous solution.

• hypotonic solutions with a sodium concentration lower than the concentration in plasma are used as common maintenance fluid therapy in pediatrics.

IntroductionIntroduction

• in healthy children, This should not be associated with any risks.

• but it may have undesired effects in ill children with a limited ability to excrete free water.

• Several stimuli for the secretion of ADH have been described, many of which are frequent among hospitalized patients.

IntroductionIntroduction

IntroductionIntroduction• fluid therapy based on hypotonic liquids

implies the administration of large a mounts of free water and, thus, this could induce iatrogenic hyponatremia..

• Recently, many authors have associated the use of hypotonic solutions with a higher incidence of hyponatremia-related permanent encephalic lesions and death.

MethodoloyMethodoloy• This is a prospective, controlled,

randomized with blind and open phases.

• conducted at the pediatric intensive care unit at the Hospital Infantil La Fe in Valencia (Spain).

• between January and March 2006.

Inclusion criteriaInclusion criteria• Children ages between 29 days and 18

years included .• only when their physician prescribed

intravenous maintenance fluid therapy.

Exclusion criteriaExclusion criteria

• Patients with chronic or acute kidney failure.

• at risk of cerebral edema (diabetic ketoacidosis or craneoencephalic trauma).

• plasma sodium levels at hospital admission 130 mEq/L or 150 mEq/L.

• And or dehydration 5% of the patient’s body weight.

Randomizasion

the isotonic group

(experimental)

sodium concentration of

140 mEq/L

the hypotonic group

(control)

sodium concentrations

between 20 and 100 mEq/L

MethodoloyMethodoloy

• In both groups, the daily total volume of liquid infused was determined by the volumetric Holliday–Segar formula.

• glucose concentrations were the same (5% dextrose).

MethodoloyMethodoloy

• The main end point is the percentage of hyponatremia acquired during treatment .

• ion blood concentrations, glucose and blood pressure were calculated at:

the time of hospital admission .

6 hrs.

24 hrs. • plasma creatinine, urine specific gravity ,

and electrolytes were calculated:

6 hrs.

MethodoloyMethodoloy

• Definitions:• Hyponatremia :<135 mEq/L.• Moderate hyponatremia:<130 mEq/L.• severe hyponatremia : <125 mEq/L. • hypernatremia :>145 mEq/L.

• Sample size calculation was based on the primary dependent end point of the study.

• the required sample was established at 122 patients.

MethodoloyMethodoloy

• MS-Excel XP program used for randomization.

• Statistical analysis was based on the intention to treat.

• SPSS program used for analysis.

• a statistical significant limit of p <0.05 .

RESULTSRESULTS

RESULTSRESULTS

Results of the first control (6 hrs)Results of the first control (6 hrs)

Urine sodium (mEq/L) 75.7 (38.5; 150.3) 127.5 (70.8; 185.7)

Patients with hypernatremia 4/63 (6.3%) 2/59 (3.3%)

Patients with hyponatremia 20/63 (31.7%) 15/59 (25.4%)

Abdominal surgery 9/19 (47.4%) 9/22 (40.9%)

Results of the second control (24 hrs)Results of the second control (24 hrs)

RESULTSRESULTS

• At the time of admission, no differences in natremia or the percentage of hyponatremia were found between groups.

• At 24 hrs, the percentage of hyponatremia in the hypotonic group was 20.6% as opposed to 5.1% in the isotonic group (p<0.02).

• No differences in the number of adverse events other than hyponatremia were observed between groups.

Critical apprasial

PICOPICO

• Population: ages between 29 days and 18 years in ICU

• Intervention: isotonic solution.

• Control: Hypotonic solution.

• Out come: adverse reactions.

RelevanceRelevance1. Does the study address a common

problem in your practice? YES2. Does the study address an important

outcome to you or to your patient? (DOE vs. POEM).

YES3. Assuming that the study conclusion is true would it lead to a change in your practice?

YES

VALIDITYVALIDITY• Were there clearly identified comparison

groups that were similar with respect to important determinants of outcome, other than the one of interest? 

• YES• Other known prognosis factors similar or

adjusted for?

• RCT, cohort, base-control?• RCT.

VALIDITYVALIDITY• Were the outcomes and exposures

measured in the same way in the groups being compared?

• YES

• Recall bias? NA• Interviewer bias? • YES• Exposure opportunity similar?• YES

VALIDITYVALIDITY• Was follow-up sufficiently long and

complete?• NO.

• Reasons for incomplete follow-up?• Mentioned and justified.

• Risk factors similar in those lost and not lost to follow-up?

• YES

• Is the temporal relationship correct (Exposure preceded outcome)?

• YES

• Risk of outcome increases with quantity or duration of exposure (dose-response gradient)?

• YES

VALIDITYVALIDITY

Results clinical significanceResults clinical significance• How strong is the association between

exposure and outcome?• How precise is the estimate of risk?• Confidence intervals?• Absolute risk increase (and its reciprocal)?

calculationcalculation

Out comeAdverse react

N Y

59 57 2 isotonic exposure

63 63 0 hypotonic

122 120 2

• Absolute Risk Increase (ARI): = |EER-CER| =(2/59 - 0/63)= 0.033.

• Number Needed to Harm (NNH): = 1/ARI = 30

Out comeAdverse react

N Y

63 50 13 hypotonic exposure

59 56 3 isotonic

122 106 16

• Absolute Risk Increase (ARI): = |EER-CER| =(13/63 – 3/59)=0.15

• Number Needed to Harm (NNH): = 1/ARI = 6

ApplicablityApplicablity• Are the results applicable to my practice?• YES

• Patients similar for demographics, morbidity and other prognostic factors

• YES

• Are treatments and exposures similar?• YES

ApplicablityApplicablity• Should I attempt to stop the exposure?• YES• Strength of evidence?• weak• Magnitude of risk?• high• Adverse effects of reducing exposure?• NO

DISCUSSIONDISCUSSION

• Limitation of study:1- incomplete follow up.

2- Incomplete blindness.

3- ethical issues.

4- important out come not included.

CONCLUSIONCONCLUSION• this study demonstrates

that isotonic fluids prevent iatrogenic hyponatremia without inducing a higher incidence of side effects.

GlossaryGlossary

• Randomization: Ideally, a process that ensures every member of a population has an equal chance to be included in the study's sample.

• Randomized Controlled Trial (RCT): A true experiment, in which the researcher randomly assigns some patients to at least one maneuver (treatment) and other patients to a placebo, or usual treatment.

GlossaryGlossary

• Intention-to-treat Analysis: analyzed for according to the groups for which they were originally assigned .

• Bias :Deviation of results from the true values.

• Recall Bias: The recall of exposures or events.

• Absolute Risk = Risk of having a disease. If the incidence of a disease is 1 in 1000, then the absolute risk is 1 in 1000 or 0.1%.

Thank you