Clinical Trials Logo

Clinical Trial Summary

The primary aim of this study is to compare mean arterial pressure (MAP) and cardiac index (CI) based intraoperative hemodynamic management in terms of postoperative high sensitive troponin elevation. The hypothesis of the study is that there will be at least 5ng/L difference between the two groups in terms of troponin elevation occurring in the postoperative period. When power analysis was performed with this primary output, it was calculated that while alpha was 0.05 beta 0.2, 42 patients in each group, a total of 84 patients were required.


Clinical Trial Description

Fluid therapy will be started as 2-4 ml/kg/h, according to the clinician's decision for the patient. Afterwards, patients will be managed hemodynamically with one of the MAP and CI algorithms. Targeted fluid therapy will be administered in accordance with the following definitions of normal and algorithms for both groups. Normal definitions: MAP: Baseline MAP +/- 20% and MAP>65mmHg Baseline MAP: MAP average in the ward at rest the day before surgery CI: Baseline CI +/- 20% and CI > 2.2 L/m2/min Baseline CI: CI calculated by MostCare monitor before the anesthesia induction starts Low MAP intervention If PPV>14, apply 500ml crystalloid If PPV>9 and any additional finding regarding hypovolemia, apply 500ml crystalloid If PPV<10, start/titrate noradrenaline infusion Low CI intervention If PPV>9, apply mini fluid challenge (MFC). If MFC is positive, apply 500ml crystalloid. If MFC is negative, evaluate MAP. If MAP is elevated start/titrate remifentanil. If MAP is not elevated start/titrate dopamine/dobutamine in accordance with SVRI ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05391087
Study type Interventional
Source Istanbul Saglik Bilimleri University
Contact
Status Completed
Phase N/A
Start date June 1, 2022
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Recruiting NCT05613439 - The Fast-track Centre for Hip and Knee Replacement Database
Recruiting NCT03740438 - Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course
Completed NCT03269760 - Multimodal Sleep Pathway for Shoulder Arthroplasty Phase 1
Recruiting NCT05594199 - Feasibility of a Virtual Smoking Cessation Program N/A
Completed NCT00538499 - Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery N/A
Recruiting NCT01690338 - A Study of Residual Curarization Incidence in China Phase 4
Recruiting NCT01110798 - J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor N/A
Completed NCT00859157 - Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer N/A
Withdrawn NCT03531268 - Prospective Study to Evaluate the Clinical Utility of Perioperative Pharmacogenomic Testing N/A
Recruiting NCT04356638 - a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients Phase 3
Completed NCT03579121 - Genomic Opioid Optimization of Dosing and Selections (GOODS) Study N/A
Completed NCT03899441 - Multimedia Aid Gynecologic Counseling and Consent N/A
Recruiting NCT06123039 - Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
Completed NCT01672892 - Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer Phase 3
Completed NCT01510652 - More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges N/A
Completed NCT01680367 - Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery N/A
Active, not recruiting NCT00005600 - Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer N/A
Recruiting NCT05743673 - SHAPE Test for Preoperative Risk Stratification