Critical Illness Clinical Trial
Official title:
The Threshold of Serum Anion Gap as a Screening Tool for Organic Acidosis
Verified date | June 2023 |
Source | Changi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: The serum anion gap (AG) is commonly used as a screening tool for acid-base disorders. With modern laboratory techniques using ion-selective electrodes to measure the main electrolyte components of the AG, our definition high AG (HAGMA) should be reviewed. Aim: This study aims to assess the diagnostic value of AG and to determine a diagnostic threshold for HAGMA in a high-prevalence clinical setting. Method: Computerized extraction of anonymised data from electronic medical records was performed. A pre-defined criteria included all inpatients of an acute-care hospital who had measurements for organic acids (lactate, ketone or salicylate) paired with a serum urea, electrolyte and creatinine panel.
Status | Completed |
Enrollment | 16475 |
Est. completion date | June 6, 2023 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Admitted from 01 July 2017 to 31 December 2019 - Patients who have had blood lactate, blood ketones and serum salicylates performed during this time period - Patient who also had urea / creatinine and a comprehensive panel of electrolytes performed up to +/-12h of blood lactate, blood ketones and serum salicylates being performed Exclusion Criteria: - Patient who did not have blood lactate, blood ketones and serum salicylates performed during this time period - Patient who did not have urea / creatinine and a comprehensive panel of electrolytes performed up to +/-12h of blood lactate, blood ketones and serum salicylates being performed |
Country | Name | City | State |
---|---|---|---|
Singapore | Changi General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Changi General Hospital |
Singapore,
Ayala-Lopez N, Harb R. Interpreting Anion Gap Values in Adult and Pediatric Patients: Examining the Reference Interval. J Appl Lab Med. 2020 Jan 1;5(1):126-135. doi: 10.1373/jalm.2019.029496. — View Citation
Lolekha PH, Vanavanan S, Lolekha S. Update on value of the anion gap in clinical diagnosis and laboratory evaluation. Clin Chim Acta. 2001 May;307(1-2):33-6. doi: 10.1016/s0009-8981(01)00459-4. — View Citation
Sadjadi SA, Manalo R, Jaipaul N, McMillan J. Ion-selective electrode and anion gap range: What should the anion gap be? Int J Nephrol Renovasc Dis. 2013 Jun 7;6:101-5. doi: 10.2147/IJNRD.S44689. Print 2013. — View Citation
Winter SD, Pearson JR, Gabow PA, Schultz AL, Lepoff RB. The fall of the serum anion gap. Arch Intern Med. 1990 Feb;150(2):311-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve of Receiver Operating Characteristics | An area under the curve (AUC) of receiver operating characteristics (ROC) of Anion Gap for the presence of organic acidosis will be calculated.
An AUC >0.8 suggests that Anion Gap performs well as a test for the presence of organic acidosis. |
End of study period, estimated 3 years | |
Primary | An optimal cut-off threshold of Anion Gap | The optimal cut-off threshold will be determined. At each cut-off level. the sensitivity and specificity will be calculated. One recommended cut-off value for Anion Gap with a sensitivity >95% will be accepted. | End of study period, estimated 3 years | |
Secondary | Subgroup Analysis for Performance of Anion Gap as a screening test for Organic Acidosis | The AUC-ROC for Anion Gap will be calculated for each patient subgroup: serum urea (=7.7 mmol/L or >7.7 mmol/L), age (below or above median age), sex, race and concomitant respiratory acid-base disorders (present or absent) | End of study period, estimated 3 years |
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