NCT06166719

Brief Summary

This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Eventually we aim to combine these methods to detect complications earlier and to give advice about whether or not administration of fluid is appropriate

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 4, 2023

Last Update Submit

December 17, 2023

Conditions

Surgery-ComplicationsOverload Fluid

Keywords

Intensive care unitGastro-intestinal surgeryPrediction

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications

    mainly complications such as ICU admission, re-OR, hemodynamic or respiratory instability, death, organ failure

    28 days

Secondary Outcomes (1)

  • fluid overload or fluid intolerance

    28 days

Other Outcomes (1)

  • renin en aldosterone activity

    28 days

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who will undergo elective, major gastrointestinal surgery.

You may qualify if:

  • ≥18 years of age.
  • elective major gastrointestinal surgery: esophagectomy, gastrectomy, pancreatomy or major liver resection (3 segments or more).

You may not qualify if:

  • no informed consent
  • Patients with major cardiac shunts
  • Patients with dialysis shunts or peritoneal dialysis
  • Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI\> 40, pulmonary fibrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peri-operative blood samples for hormone levels and liver metabolism e.g. Whole blood and serum

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • A.P. J. Vlaar, PhD

    Department of Intensive Care, Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

P. Klompmaker, PhD

CONTACT

020 444 4444p.klompmaker@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

November 20, 2023

Primary Completion

November 20, 2025

Study Completion

January 20, 2026

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations

NL(1)