NCT07349186

Brief Summary

The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having robot-assisted radical prostatectomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress27%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 8, 2026

Last Update Submit

January 30, 2026

Conditions

Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

  • Time-weighted average MAP <65 mmHg

    Time-weighted average MAP \<65 mmHg \[mmHg\], calculated from the start of surgery until the end of surgery (continuous endpoint)

    From the start of surgery until the end of surgery

Secondary Outcomes (7)

  • Area under a MAP <65 mmHg

    From the start of surgery until the end of surgery

  • Total duration of MAP <65 mmHg

    From the start of surgery until the end of surgery

  • Number of discrete hypotensive episodes

    From the start of surgery until the end of surgery

  • Area above a MAP >100 mmHg

    From the start of surgery until the end of surgery

  • Time-weighted average MAP >100 mmHg

    From the start of surgery until the end of surgery

  • +2 more secondary outcomes

Other Outcomes (6)

  • Incidence of a composite binary outcome defined as the occurrence of at least one of the following: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death

    Within the first 30 postoperative days

  • Incidence of need for renal replacement therapy

    Within the first 30 postoperative days

  • Incidence of myocardial infarction

    Within the first 30 postoperative days

  • +3 more other outcomes

Study Arms (2)

Oscillometric blood pressure monitoring

EXPERIMENTAL

Intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring.

Other: Oscillometric blood pressure monitoring

Intraarterial blood pressure monitoring

ACTIVE COMPARATOR

Intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring.

Other: Intraarterial blood pressure monitoring

Interventions

Oscillometric blood pressure monitoringOTHER

In patients assigned to oscillometric blood pressure monitoring, clinicians will be blinded to intraarterial blood pressure monitoring and intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring at 2.5-minute intervals.

Oscillometric blood pressure monitoring
Intraarterial blood pressure monitoringOTHER

In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.

Intraarterial blood pressure monitoring

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male patient ≥18 years
  • scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position
  • planned intraarterial blood pressure monitoring

You may not qualify if:

  • patients in whom the attending anesthesiologist considers intraarterial blood pressure monitoring to be mandatory for clinical reasons
  • patients participating in another interventional trial likely to influence intraoperative blood pressure management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Central Study Contacts

Alina Bergholz

CONTACT

004940 7410 0a.bergholz@uke.de

Bernd Saugel

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

DE(1)