GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery

NCT01401283 | Completed Results

• 1 other identifier: 797726
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients

Conditions

Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative Complications

  Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output \<500ml/d, ARF)

  Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days

Secondary Outcomes (1)

• Hospital Stay

  Participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (2)

Study group

ACTIVE COMPARATOR

intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation, measurement of cardiac output and pulse pressure variation, hemodynamic optimization according to cardiac index and pulse pressure variation

Device: measurement of cardiac output and pulse pressure variation

Control group

NO INTERVENTION

hemodynamic management according to institutional clinical standards

Interventions

measurement of cardiac output and pulse pressure variation DEVICE

hemodynamic optimization according to cardiac index and pulse pressure variation

Study group

Eligibility Criteria

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

You may qualify if:

• major abdominal surgery
• duration of surgery \> 2 hours

You may not qualify if:

• age \< 18 years
• scheduled postoperative icu treatment

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Northern State Medical University: collaborator
• Szeged University: collaborator
• University of Kiel: collaborator
• University of Witten/Herdecke: collaborator
• University of Valencia: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (1)

• Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.

  PMID: 24010849 DERIVED

Results Point of Contact

• Title: Daniel A. Reuter, MD
• Organization: Hamburg Eppendorf University Hospital

dreuter@uke.de

+49-40-7410-0

Study Officials

• Daniel A Reuter, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 25, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 5, 2016
• Results First Posted: February 5, 2016

Record last verified: 2016-01

Locations

DE (1)