Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04061655
Other study ID # FMASU R 03/ 2019
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 20, 2019
Est. completion date January 10, 2020

Study information

Verified date January 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A total of 80 patients will be randomly allocated into 2 groups, group A and placebo group using concealed envelope method.Group A patients (n= 40)will receive single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. Patients in the placebo group (n=40) will receive as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.


Description:

A total of 80 patients will randomly allocated into 2 groups, group A and placebo group using concealed envelope method.Group A patients (n= 40) will receive single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. Patients in the placebo group (n=40) will receive as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

General anesthesia will the institutional standards and all surgeries will be performed by the same surgical team.Standardized monitoring will be applied.After median sternotomy,CPB will be established with 1500 ml crystalloid priming volume and mild hypothermia (32°C) with a Trillium Affinity oxygenator (Medtronic,Minneapolis, Minnesota, USA) and a Sarns CPB machine (Harrison, Mt. Clemens, Michigan, USA) at a flow rate of 2.6 lmin−1m−2.Myocardial protection will be done using cold blood cardioplegia at 20°C. During CPB, homologous donor packed red blood cells will be transfused if hemoglobin was less than 6.5 gdl−1.During bypass, anticoagulation for extracorporeal circulation was performed using heparin 300 U/kg administered into the right atrium. Acelite activated clotting time (ACT) greater than 400 was considered adequate for commencing CPB; if less, an additional dose of 100Uof heparin will be adminstered.CPB will be conducted using nonocclusive roller pumps, arterial line filtration ,membrane oxygenators, , and blood-enriched cold hyperkalemic arrest. Systemic hypothermia documented by an esophageal temperature of 32°C will be maintained during aortic cross clamping.After completion of CPB and removal of the arterial cannula, heparin will be neutralized with 1 mg of protamine sulfate adminstered for every 100U of heparin over a period of 15 minutes . Eventually, a second dose of protamine 50 mg will be given if ACT remained above baseline. All patients will be transferred to ICU after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 10, 2020
Est. primary completion date January 6, 2020
Accepts healthy volunteers No
Gender All
Age group 52 Years to 73 Years
Eligibility Inclusion Criteria:

- patients aged 52-73 years old

- ASA II/III

- elective CABG

- hemoglobin level at baseline for males >13.0 g/dl and for females >12.0 g/dl.

Exclusion Criteria:

- Patients with known hypersensitivity to iron sucrose

- history of hepatitis B or C or human immunodeficiency virus

- folate or vitamin B12deficiency, history of unstable angina,

- active severe infection

- suspicion of iron overload (ferritin > 300 µg/l ), or autologous blood transfusion in the previous month pregnancy and nursing impaired renal function defined by s-creatinine >150 µmol/L patients received any iron preparations in the previous month -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Iron Isomaltoside 1000
Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg.
Other:
placebo
Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.

Locations

Country Name City State
Egypt Ain Shams university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary haemoglobin concentration change the change in the Hb concentration at baseline, intraoperative, at discharge and 1 week after discharge in non-anaemic patients undergoing cardiac surgery. 1 week after discharge from hospital
Secondary hospital stay duration of hospital stay 7 to 10 days
See also
  Status Clinical Trial Phase
Recruiting NCT02228473 - Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort N/A
Recruiting NCT02246153 - Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients Phase 3
Recruiting NCT01917253 - Standard Length Catheters vs Long Catheters in Peripheral Vein Cannulation. N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT01574196 - Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood N/A
Completed NCT02447523 - The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy N/A
Terminated NCT00616824 - The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction Phase 4
Recruiting NCT03984747 - Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
Completed NCT03641365 - Sleeves Versus Sleeveless Template N/A
Completed NCT02901665 - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes N/A
Completed NCT02675166 - Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Completed NCT01997658 - Preoperative Glucocorticoid Use in Major Hepatectomy Phase 2/Phase 3
Not yet recruiting NCT02252445 - Propofol and Sevoflurane for Catheter-Related Bladder Discomfort N/A
Active, not recruiting NCT01775150 - Saving Mother and Baby With Text Messaging N/A
Completed NCT01631799 - Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia N/A
Completed NCT03440138 - Defining Benchmarks in Bariatric Surgery
Recruiting NCT02835404 - Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer Phase 2
Completed NCT01489800 - The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer N/A
Completed NCT02096224 - Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort N/A
Completed NCT01531478 - Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France N/A