NCT00725972

Brief Summary

Several recent clinical trials have documented that early aggressive resuscitation approached guided by defined hemodynamic variables using thoughtful protocols may improve outcome. The concept underscored by this newer trial was that appropriate resuscitation prevents subsequent tissue injury even if overt shock is present, if the resuscitation is carried out early enough.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

First QC Date

July 22, 2008

Last Update Submit

July 30, 2017

Conditions

Hemorrhage

Keywords

ImprovePatient careApplyingSystematicFashionProvenResuscitationAlgorithmsHigh riskSurgical

Outcome Measures

Primary Outcomes (1)

  • Duration of mechanical ventilation. Duration of ICU and hospital stay. Infection Renal function. Bowel movement. Oral intake. 3-month period Quality of life.

    3 months

Secondary Outcomes (1)

  • As in the primary

    3 months

Study Arms (2)

Augmented Oxygen Delivery Group

EXPERIMENTAL

Hemodynamic management to a goal of O2 delivery of 600 ml/m2/min utilizing cardiac stroke volume variation with positive pressure ventilation to optimize fluid management. Intervention: Augment O2 Delivery by hemodynamic protocol. (7/30/17: deleted original text which apparently was pasted from an entirely unrelated study having to do with age of transfused blood, presumably by the creator of this record, Cynthia Hatfield, in 2010. SLW)

Other: Augment O2 Delivery by hemodynamic protocol

Control

SHAM COMPARATOR

Patients having the same types of surgery but receiving usual anesthetic care. Intervention: High Risk Surgery. (7/30/17: deleted original text which apparently was pasted from an entirely unrelated study having to do with age of transfused blood, presumably by the creator of this record, Cynthia Hatfield, in 2010. SLW)

Procedure: High Risk Surgery

Interventions

Augment O2 Delivery by hemodynamic protocolOTHER

Hemodynamic management to a goal of O2 delivery of 600 ml/m2/min utilizing cardiac stroke volume variation with positive pressure ventilation to optimize fluid management.

Augmented Oxygen Delivery Group
High Risk SurgeryPROCEDURE

Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, Male or female.
  • Patients undergoing elective major surgery.
  • Patients with normal renal function.
  • All patients will sign informed consent.

You may not qualify if:

  • Major organ failure.
  • Low cardiac output conditions.
  • Pulmonary hypertension.
  • Severe pulmonary disease.
  • Patient refusal to participate in the study.
  • Pregnancy.
  • Emergency Surgery.
  • Lithium allergy or patient on lithium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC-Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven L Whitehurst, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants undergo anesthesia and are unaware of the arm they are in. Outcomes Assessors are only given data on results and are kept unaware of the peri-operative management.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A protocol group receiving augmented Oxygen Delivery will be compared to a usual care group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 31, 2008

Study Start

July 1, 2008

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

US(1)