NCT03795467

Brief Summary

The peripheral perfusion index (PPI) is a non-invasive, feasible measure of peripheral perfusion and, assumed, the overall circulation, which all patients are monitored by. This study is carried out to assess the association between values of PPI, haemoglobin and blood transfusion. Hypothetically, patients with low values of hb are more susceptible to a deteriorating circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with blood products improves PPI measurements. Moreover, that patients with low values of PPI have more surgical complications and higher mortality.

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
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

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 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 2, 2019

Last Update Submit

January 4, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Peripheral perfusion index

    Absolute PPI levels

    Perioperative with 5 minute interval

  • Haemoglobin level

    Measurement of haemoglobin by blood sample or artery gas.

    Time interval: From 3 hours preoperative to 10 hours postoperative

Secondary Outcomes (3)

  • Evaluation of Peripheral perfusion index in patients with high vs. low haemoglobin levels in relation to mean arterial blood pressure (MAP).

    Perioperative

  • Proportion of transfusion with blood products in patients with perioperative high vs. low haemoglobin levels.

    Perioperative

  • Evaluation of peripheral perfusion index changes in patients with perioperative high vs. low haemoglobin levels in relation to transfusion with blood products .

    Perioperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients \> 18 years of age having performed acute abdominal or orthopedic surgery from 1th November 2017 through 31th October 2018 at Hvidovre and Bispebjerg University Hospitals. Study subjects will be obtained from the hospitals electronic medical records via specific procedural- or diagnostic codes representing the acute orthopedic or abdominal surgery in the specified one-year period.

You may qualify if:

  • Orthopedic surgery patients with fracture of the hip, booked in the electronic patient record for operation with procedural codes:KNFB02 HNFJ81 KNFJ51 KNFJ52 KNFJ70
  • Acute abdominal surgery patients booked in the electronic patient record for operation with procedural codes:KJAH01 KJAH00

You may not qualify if:

  • No sampling of PPI registered
  • Foreign/temporary civil registration number
  • Already included in cohort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Hvidovre Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

  • Lau FF, Agerskov M, Thusholdt ANW, Hojlund J, Meyhoff CS, Jans O, Foss NB. Peripheral perfusion index stratifies risk in patients with intraoperative anemia: A multicentre cohort study. J Clin Anesth. 2024 Aug;95:111472. doi: 10.1016/j.jclinane.2024.111472. Epub 2024 Apr 12.

MeSH Terms

Conditions

Hip FracturesIleusAnastomotic Leak

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Research Fellow

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 7, 2019

Study Start

November 1, 2017

Primary Completion

October 31, 2018

Study Completion

June 1, 2019

Last Updated

January 7, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations