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.
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
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.
- Conditions
- Anemia, Iron Deficiency, Hyperglycemia
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diagnosis of diabetes and anaemia
Proportion of patients with diagnosis of diabetes and anaemia
Measured: Day of surgery
Secondary outcomes (3)
HbA1C level
Assessment of diabetic control
Measured: Day of surgery
Transferrin saturation
Diagnosis of iron deficiency anaemia
Measured: Day of surgery
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.
- First posted23 Oct 2017
- Study start16 Oct 2017
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Biccard, University of Cape Town
- Investigators
- Netjhardt Marcin, MBChB, FCA, Principal investigator, University of Cape TownFrancois Roodt, MBChB, FCA, Principal investigator, University of Cape Town
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Perioperative Interventions to Improve Patient Outcomes (EPIC-1) Study
- ClinicalTrials.gov ID
- NCT03318055
- Acronym / sponsor ID
- EPIC-1 / EPIC1
- Conditions
- Anemia, Iron Deficiency, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Adult, non-cardiac, non-obstetric, elective surgical patients
Key exclusion criteria (1 listed)
- Obstetric, emergency and cardiac patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of diagnosis of diabetes and anaemia
Time frame: Day of surgery
Proportion of patients with diagnosis of diabetes and anaemia
3 secondary outcomes
HbA1C level
Time frame: Day of surgery
Transferrin saturation
Time frame: Day of surgery
Serum ferritin
Time frame: Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Netjhardt Marcin, MBChB, FCA principal investigator
University of Cape Town
Francois Roodt, MBChB, FCA principal investigator
University of Cape Town
6 sites in 1 country: see every site and its status.
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.