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*Implementation of a symptom based algorithm for calcium management after total thyroidectomy *

*Implementation of a symptom based algorithm for calcium management after total thyroidectomy * - IMPACT-trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45592
Enrollment
100
Registered
2017-02-22
Start date
2017-04-07
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypocalcemia hypoparathyroidism low calcium bloodlevel

Interventions

New treatment algorithm

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Indication for total thyroidectomy or completion thyroidectomy 2. Patient age 18 years or older at the time of inclusion

Exclusion criteria

Exclusion criteria: 1. Pre-operative abnormal adjusted serum calcium level (reference range 2.20 -2.55 mmol/L) 2. Hyperparathyroidism 3. Planned parathyroidectomy 4. History of epileptic seizures 5. Pregnancy 6. Non dutch speaking 7. Not able to give informed consent

Design outcomes

Primary

MeasureTime frame
The primary study endpoint is the difference in the percentage of patients treated with calcium (and active vitamin D3-metabolite) supplements before and after implementation of the new algorithm.

Secondary

MeasureTime frame
1. Number of readmissions for intravenous calcium supplementation 2. Number of calcium related contacts with the outpatient department 3. The incidence of hypocalcemia: both transient and permanent 4. Risk factors for hypocalcemia (patient or surgery related) 5. Incidence of hypocalcemic symptoms emerging after discharge 6. Complications related to hypocalcemia 7. Duration of admission 8. Number of patients requiring intravenous calcium supplementation 9. Relation between EKG abnormalities and hypocalcemia

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)