EFFECT OF VASOPRESSORS ON FLUID CHALLENGE PERSISTENCE AN OBSERVATIONAL STUDY IN PATIENTS UNDERGOING LAPAROTOMY.

NCT04934345 | Unknown

• 1 other identifier: NORA_FC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The hemodynamic effect of the fluid challenge administration (FC) depends on different variables related to the interplay between cardiac function and vascular tone response. In this context, the effect of adding a vasopressor to keep the arterial pressure between predefined ranges may impact on the persistence of stroke volume (SV) changes after FC administration. In fact, both the effect on arterial elastance and venous return may increase the persistence of SV increase, which is know to drop to baseline pre-FC values within fw minutes after FC administration. This single-centre observational study, in elective patients scheduled for elective laparotomy, hypothesizes that intraoperative norepinephrine infusion would prolong the effect of FC administration.

Conditions

Fluid Challenge; Pharmakodynamic; Norepinephrine; Surgery

Outcome Measures

Primary Outcomes (1)

• Stroke volume persistance

  Stroke volume estimation with respect to baseline values

  evaluated within 10 minutes after fluid challenge infusion

Secondary Outcomes (3)

• Pharmakodynamic assesement of FC with and without NE

  evaluated within 10 minutes after fluid challenge infusion

• dmax

  evaluated within 10 minutes after fluid challenge infusion

• tmax

  evaluated within 10 minutes after fluid challenge infusion

Study Arms (1)

FC administration

* All the patients receive crystalloids at 4 ml/kg/hour as maintenance fluid during surgery, according to standard practice. * After the first episode of hypotension (MAP \< 65 mmHg) the PPV is checked. * PPV ≥ 13% - FC (4 ml/kg of crystalloids administered in 10') * PPV \< 13% - start norepinephrine (starting dose - 0.05 mcg/kg/min). In this group, the FC will be administered during an episode of intraoperative hypotension during NE infusion.

Diagnostic Test: Fluid challenge

Interventions

Fluid challenge DIAGNOSTIC_TEST

The fluid challenge consists of a bolus of 4 ml/kg of crystalloids, administered over 10 minutes.

FC administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective surgical patients scheduled for laparotomy \>3h

You may qualify if:

• adult patients, scheduled for elective laparotomy (\>3h predicted) and requiring a FC.

You may not qualify if:

• any recurrent cardiac arrhythmia;
• reduced left (ejection fraction \< 30%) or right (systolic peak velocity of tricuspid annular motion \< 0.17 m/s) ventricular systolic function.
• Once enrolled, the patient can be additionally excluded due to the occurrence of one of the following intraoperative conditions:
• significant bleeding (more than 500 ml in ½ hour)
• recurrent extrasystoles
• persistent low quality of the arterial signal affecting hemodynamic monitoring measurements
• intraoperative hemodynamic instability requiring the persistent use of vasopressors.

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Related Publications (3)

• Aya HD, Ster IC, Fletcher N, Grounds RM, Rhodes A, Cecconi M. Pharmacodynamic Analysis of a Fluid Challenge. Crit Care Med. 2016 May;44(5):880-91. doi: 10.1097/CCM.0000000000001517.

  PMID: 26683506 BACKGROUND

• Vincent JL. Fluid management in the critically ill. Kidney Int. 2019 Jul;96(1):52-57. doi: 10.1016/j.kint.2018.11.047. Epub 2019 Mar 4.

  PMID: 30926137 BACKGROUND

• Monnet X, Teboul JL. Assessment of fluid responsiveness: recent advances. Curr Opin Crit Care. 2018 Jun;24(3):190-195. doi: 10.1097/MCC.0000000000000501.

  PMID: 29634494 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

IT (1)