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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency laparotomy, obstruction | Patients undergoing emergency laparotomy for intestinal obstruction in need of intraoperative Noradrenaline infusion to maintain predefined normotension. | ||
| Emergency laparotomy, perforation | Patients undergoing emergency laparotomy for perforated ventricle or intestine in need of intraoperative Noradrenaline infusion to maintain predefined normotension. |
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| Measure | Description | Time Frame |
|---|---|---|
| Preload dependency | the incidence of preload dependency defined as stroke volume increase of >10% during fluid challenge after reduction of Noradrenaline. | intraoperatively (during general anesthesia) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperatively (during general anesthesia) |
| Tissue perfusion |
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Inclusion Criteria:
Adults (18 years or over) undergoing emergency laparotomy/laparoscopy for following abdominal pathology:
Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, anastomotic leakage
Provided verbal and written informed consent
Must speak and understand the Danish language
Intraoperative indication for Norepinephrine infusion
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Hvidovre | Recruiting | Hvidovre | Denmark |
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| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Other endpoints of interest are the correlation between gut perfusion and indices of central and peripheral perfusion (urethral, cerebral, tissue).
| intraoperatively (during general anesthesia) |