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Anemia, Iron DeficiencyEPIC-1NCT03318055

Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients

An observational study of Anemia, Iron Deficiency and Hyperglycemia, run by University of Cape Town at 6 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a prospective, observational study of adult, non-cardiac, non-obstetric, elective surgical patients conducted over a period of one week. This large-scale clinical audit aims to assess the incidence rates of anaemia and hyperglycaemia amongst elective surgical patients in the Western Cape. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Iron Deficiency, Hyperglycemia
How many people
343 participants
Where
6 sitesSouth Africa
Study dates
16 Oct 2017to 20 Oct 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: The study population comprises all adult non-cardiac, non-obstetric patients presenting for elective surgery over a period of one week at following sites: Groote Schuur -, Somerset -, Paarl -, Victoria -, Mitchell's Plain - and George Hospital.

Who may be able to join

  • Adult, non-cardiac, non-obstetric, elective surgical patients

Who cannot join

  • Obstetric, emergency and cardiac patients

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Africa6 sites
  • Groote Schuur Hospital

    Cape Town, Western Cape, 7599

  • Mitchells Plain Hospital

    Cape Town, Western Cape, 7599

  • Somerset Hospital

    Cape Town, Western Cape, 7599

  • Victoria Hospital

    Cape Town, Western Cape, 7599

  • George Hospital

    George, Western Cape, 7599

  • Paarl Hospital

    Paarl, Western Cape, 7599

Other trials in South Africa

About this study

Official title: Evaluating Perioperative Interventions to Improve Patient Outcomes (EPIC-1) Study

The study is a prospective, observational study of adult, non-cardiac, non-obstetric, elective surgical patients conducted over a period of one week. This large-scale clinical audit aims to assess the incidence rates of anaemia and hyperglycaemia amongst elective surgical patients in the Western Cape. A study such as this is essential in the assessment of the incidence rates of abnormal fasting blood glucose levels and reduce the risk of perioperative complications for patients. Preoperative anaemia is a modifiable risk factor and should be identified early and treated appropriately to improve patient outcomes.

Read the detailed description

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.

Medical subject headings
Anemia, Iron-Deficiency, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03318055
Study groupRoleWhat they receive
Single group studyThe 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of diagnosis of diabetes and anaemia

    Proportion of patients with diagnosis of diabetes and anaemia

    Measured: Day of surgery

Secondary outcomes (3)
  1. HbA1C level

    Assessment of diabetic control

    Measured: Day of surgery

  2. Transferrin saturation

    Diagnosis of iron deficiency anaemia

    Measured: Day of surgery

  3. Serum ferritin

    Diagnosis of iron deficiency anaemia

    Measured: Day of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start16 Oct 2017
  3. Primary completion20 Oct 2017
  4. Study completion20 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03318055
Sponsor's protocol ID
EPIC1
Acronym
EPIC-1
Status last verified
May 2018
First submitted
6 Oct 2017
Last updated
14 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, Iron Deficiency and Hyperglycemia, run by University of Cape Town at 6 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of diagnosis of diabetes and anaemia (time frame: Day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.

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