An observational study in Emergency Laparotomy, Intestinal Obstruction and Perforated Viscus, sponsored by Copenhagen University Hospital, Hvidovre. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Copenhagen University Hospital, Hvidovre · Observational
This study is investigating the effect of intraoperative Noradrenaline on cardiac preload and stroke volume, after initial fluid resuscitation, in order to assess whether there is a masked preload responsiveness and ultimately whether the correction of this potential preload-responsiveness with fluid therapy will translate into increased tissue perfusion in emergency laparotomy.
Early detection and treatment of insufficient tissue perfusion and oxygenation is the main purpose of perioperative haemodynamic monitoring and management. Hypovolemia, septicaemia, and low flow states affecting central and peripheral perfusion are frequent in patients undergoing emergency laparotomy.
This study aims to assess the effects of Noradrenaline (NA) on cardiac preload, and tissue perfusion in patients undergoing emergency laparotomy, to investigate potential macro/microcirculatory uncoupling.
A single-centre, prospective interventional non-blinded single-arm study at the Department of Anaesthesiology and Intensive care Unit, Copenhagen University Hospital Hvidovre, Denmark. We will include patients undergoing emergency laparotomy. The study start is January 2021. After informed consent, patients will be included if they have an intraoperative need for Noradrenaline infusion >0.1 mcg/kg/min to maintain MAP ≥65 mmHg after resuscitation with a goal-directed fluid therapy algorithm. 20 patients will be included.
Intervention: At a steady state (MAP ≥65 mmHg) during the surgical procedure, we will reduce NA to investigate whether patients will be preload responsive while maintaining MAP > 50 mmHg and limiting stroke volume reduction to no more than 30%. After a subsequent fluid challenge, we will increase the dose of NA to re-establish a MAP ≥65 mmHg. In addition, peripheral and central perfusion indices, including gut perfusion, will be measured.
160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.
This study's planned enrollment of 20 is below the median of 152 across 68 observational studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →Copenhagen University Hospital, Hvidovre is the lead sponsor of 76 studies on the registry; 17 are open to participants now.
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This study will include patients undergoing emergency laparotomy on suspicion of abdominal pathology, in need of intraoperative Noradrenaline infusion to maintain predefined normotension.
Adults (18 years or over) undergoing emergency laparotomy/laparoscopy for following abdominal pathology:
Exclusion Criteria:
Patients undergoing emergency laparotomy for intestinal obstruction in need of intraoperative Noradrenaline infusion to maintain predefined normotension.
Patients undergoing emergency laparotomy for perforated ventricle or intestine in need of intraoperative Noradrenaline infusion to maintain predefined normotension.
Preload dependency
the incidence of preload dependency defined as stroke volume increase of \>10% during fluid challenge after reduction of Noradrenaline.
Time frame: intraoperatively (during general anesthesia)
Tissue perfusion and fluid status
changes in perfusion indices (delta values) after NA reduction, one fluid bolus, and subsequent restoration of blood pressure with Noradrenaline.
Time frame: intraoperatively (during general anesthesia)
Tissue perfusion
Other endpoints of interest are the correlation between gut perfusion and indices of central and peripheral perfusion (urethral, cerebral, tissue).
Time frame: intraoperatively (during general anesthesia)
Plan to share: No
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital, Hvidovre