Trial Outcomes & Findings for GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery (NCT NCT01401283)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

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

Results posted on

2016-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Study Group 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	Control Group hemodynamic management according to institutional clinical standards
Overall Study STARTED	89	91
Overall Study COMPLETED	79	81
Overall Study NOT COMPLETED	10	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Group 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	Control Group hemodynamic management according to institutional clinical standards
Overall Study surgery cancelled	5	8
Overall Study preoperative arrhythmia	5	0
Overall Study no central venous access	0	1
Overall Study suspicion of malignant hyperthermia	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=89 Participants 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	Control Group n=91 Participants hemodynamic management according to institutional clinical standards	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	55 Participants n=7 Participants	119 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	36 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Region of Enrollment Germany	89 participants n=5 Participants	91 participants n=7 Participants	180 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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)

Outcome measures

Outcome measures
Measure	Study Group n=89 Participants 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	Control Group n=91 Participants hemodynamic management according to institutional clinical standards
Postoperative Complications	52 numbers of complications	72 numbers of complications

SECONDARY outcome

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

length of stay in the postoperative care unit, length of hospital stay

Outcome measures

Outcome measures
Measure	Study Group n=89 Participants 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	Control Group n=91 Participants hemodynamic management according to institutional clinical standards
Hospital Stay	11 days Interval 7.0 to 15.0	10 days Interval 4.1 to 15.9

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel A. Reuter, MD

Hamburg Eppendorf University Hospital

Phone: +49-40-7410-0

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place