An observational study in Diabetic Ketoacidosis, sponsored by Jahra Hospital. Completed at 1 site in Kuwait. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Jahra Hospital · Observational
Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.
Diabetic ketoacidosis (DKA) is one of the most severe acute metabolic complications of diabetes mellitus (DM). Therefore, DKA patients require prompt treatment and any delay in identifying severe DKA cases can lead to worse outcomes. DKA provokes a systemic inflammatory response through increased levels of various cytokines such as interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α), and IL-1B. This will lead to cellular activation, cellular adhesion, increased oxidative stress, and endothelial damage, possibly contributing to complications. Consequently, surrogate markers of inflammation and immune status may help in the early identification of patients with severe DKA.
The systemic immune-inflammation index (SII) had a better prognostic value compared to NLR and PLR among cancer patients. Recently, studies have suggested a link between SII and increased risk of atherosclerotic cardiovascular disease (ASCVD), hepatic steatosis, and worse outcomes among hypertensive patients and patients with stroke.
Therefore, the investigators aim to examine SII as a marker of severity in T1DM patients with DKA in an uninfected state.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 241 is close to the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with Jahra Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Type 1 DM hospitalized because of DKA.
Exclusion Criteria:
pH \< 7.3 or serum bicarbonate \<18 mmol/L
Other: DKA protocol
pH \< 7.2 or serum bicarbonate \<10 mmol/L
Other: DKA protocol
pH \< 7.1 or serum bicarbonate \<5 mmol/L
Other: DKA protocol
IV fluids and IV insulin as per guidelines. reference 1-2
SII
SII = (neutrophil × platelet) / lymphocyte.
Time frame: Day 1 (baseline)
ICU admission
need for ICU admission
Time frame: Hospital stay up to one week
readmission
readmission because of DKA
Time frame: within 90 days
Plan to share: Undecided — Datasets analyzed during the current study will be available upon reasonable request from the corresponding author and after IRB approval.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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