- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03318055
Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients (EPIC-1)
Evaluating Perioperative Interventions to Improve Patient Outcomes (EPIC-1) Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Globally, one third of patients presenting for surgery will be anaemic, according to the WHO criteria. Preoperative anaemia is considered an independent risk factor for poorer patient outcomes, with increases in morbidity and mortality as well as prolonged length of hospital stay. However, the importance of this finding in the preoperative period is often overlooked and not corrected prior to surgery. The leading cause of preoperative anaemia is iron deficiency. Iron deficiency anaemia is common in developing countries and results mostly from nutritional deficiency. Poorly controlled Diabetes Mellitus (DM) is known to have an adverse effect on perioperative clinical outcomes, with an extended length of hospital stay and increased morbidity and mortality. Preoperative identification of patients with DM, provides a potential opportunity to reduce the risk of adverse surgical outcomes. Early identification of such patients could facilitate timely intervention and arrangement of appropriate perioperative and long-term follow-up. Studies have demonstrated that an elevated HbA1c (indicative of poor glycaemic control in the months preceding surgery) correlates with increased perioperative risk in known diabetics. On the day of surgery, before induction of anaesthesia, all patients will have a finger prick blood glucose level done by point of care glucometry, if there is no documented fasting blood glucose value in their ward file. In patients of unknown diabetic status, should the preoperative value be >7 mmol/l, blood will be drawn when IV access is established, for HbA1C measurement. In known diabetics, a sample will be taken for HbA1C, regardless of the preoperative fasting blood glucose level, unless there is an HbA1C measurement in the previous 3 months. However, should the patient management have been modified based on the HbA1C result, a repeat HbA1C measurement would be performed
All patients will be assessed as part of the routine preoperative evaluation. Informed consent will be obtained by the anaesthetist from eligible patients who agree to participate in the study. On the day of surgery, prior to induction of anaesthesia the patients will receive a finger prick Hemoglobin (Hb) if they have not had a Hb result documented within the last 3 months. If the results meet the WHO criteria for anemia, a blood specimen will be collected when inserting the IV line. The blood specimen will be sent for Haemoglobin, mean cell volume, ferritin and transferrin saturation (TSAT) testing. All patients diagnosed with anemia will receive a patient information leaflet. They will also be referred to their local clinics or general practitioner for further evaluation and appropriate management.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Western Cape
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Cape Town, Western Cape, Afrique du Sud, 7599
- Mitchells Plain Hospital
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Cape Town, Western Cape, Afrique du Sud, 7599
- Somerset Hospital
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Cape Town, Western Cape, Afrique du Sud, 7599
- Victoria Hospital
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Cape Town, Western Cape, Afrique du Sud, 7599
- Groote Schuur Hospital
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George, Western Cape, Afrique du Sud, 7599
- George Hospital
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Paarl, Western Cape, Afrique du Sud, 7599
- Paarl Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adult, non-cardiac, non-obstetric, elective surgical patients
Exclusion Criteria:
- Obstetric, emergency and cardiac patients
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Single group study
The study population will include patients presenting for elective surgery, who fulfil the inclusion criteria of all surgical disciplines undergoing elective surgery period during the period of the study. Inclusion Criteria: > 18 years of age Non-cardiac patients Non-obstetric patients Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Prevalence of diagnosis of diabetes and anaemia
Délai: Day of surgery
|
Proportion of patients with diagnosis of diabetes and anaemia
|
Day of surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
HbA1C level
Délai: Day of surgery
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Assessment of diabetic control
|
Day of surgery
|
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Transferrin saturation
Délai: Day of surgery
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Diagnosis of iron deficiency anaemia
|
Day of surgery
|
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Serum ferritin
Délai: Day of surgery
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Diagnosis of iron deficiency anaemia
|
Day of surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Netjhardt Marcin, MBChB, FCA, University of Cape Town
- Chercheur principal: Francois Roodt, MBChB, FCA, University of Cape Town
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EPIC1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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