Blood Loss, Surgical Clinical Trial
Official title:
Impact of Hyperoncotic Albumin to Support Blood Loss Replacement on Plasma Volume Expansion in Cystectomy Patients.
Fluid treatment is usually performed with either balanced crystalloid fluids or iso-oncotic
colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about
synthetic colloids (impairment of renal function and coagulation), and the natural albumin
has been used more extensively. Albumin is the main protein responsible for plasma oncotic
pressure and its volume expansion effect. An alternative therapeutic option is the
mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20%
albumin solution (endogenous fluid recruitment).
The primary objective of this study is to test the effect of 20% albumin on plasma volume
expansion and fluid recruitment in the frame of blood loss replacement during cystectomy
using established fluid kinetic models.
The investigators expect that fluid replacement with crystalloid will be better sustained
intravascularly with the administration of 20% albumin and be able to recruit fluid into the
vascular compartment.
Bladder cancer occurs mainly in old comorbid patients. The standard treatment of localized
muscle invasive bladder cancer is pelvic lymph node dissection and open radical cystectomy
with urinary diversion. Optimal perioperative fluid management for this surgery is
challenging and still controversial in terms of how much to perfuse, choice of fluids
(crystalloids and colloids) to restore hydrated state and volemia.
Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic
synthetic colloids, plasma or 5% albumin. Because crystalloids quickly equilibrate between
the intravascular and interstitial volumes, they are mainly used to treat dehydration and
temporary volume deficits. Iso‐oncotic colloids remain intravascular for a prolonged period.
Doubts have been raised about synthetic colloids, and the natural albumin has been used more
extensively. Albumin is the main protein responsible for plasma oncotic pressure and its
volume expansion effect. An alternative therapeutic option is the mobilization of tissue
fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution
(endogenous fluid recruitment).
There are still unknown aspects of the physiological effects of hyper-oncotic albumin. One of
them is the, in this study investigated, effect of 20% albumin on plasma volume expansion,
fluid recruitment, and crystalloid kinetic in the frame of blood loss replacement during
cystectomy.
It is expected that fluid replacement with crystalloid will be better sustained
intravascularly with the administration of 20% albumin.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04114253 -
QStat in Liver Transplant
|
||
Recruiting |
NCT05077124 -
Safe and Timely Antithrombotic Removal (STAR) Registry
|
||
Active, not recruiting |
NCT03651154 -
Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections
|
N/A | |
Recruiting |
NCT04519593 -
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
|
N/A | |
Completed |
NCT02043132 -
Tranexamic Acid in Reverse Total Shoulder Arthroplasty
|
Phase 2/Phase 3 | |
Withdrawn |
NCT00861367 -
Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate
|
N/A | |
Terminated |
NCT03246919 -
Ideal Time of Oxytocin Infusion During Cesarean Section
|
Phase 4 | |
Completed |
NCT04443920 -
Tranexamic Acid for Total Knee Arthroscopy
|
Phase 4 | |
Withdrawn |
NCT04933253 -
Mediastinal Temperature and Post-operative Bleeding
|
N/A | |
Recruiting |
NCT02938962 -
Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X)
|
Phase 4 | |
Recruiting |
NCT02130752 -
Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery
|
N/A | |
Recruiting |
NCT05164809 -
Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery
|
||
Not yet recruiting |
NCT04574128 -
Retransfusion or Not of Cardiotomy Blood
|
N/A | |
Completed |
NCT02911831 -
IV Tranexamic Acid Prior to Hysterectomy
|
Early Phase 1 | |
Completed |
NCT02740374 -
Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery
|
N/A | |
Enrolling by invitation |
NCT05474027 -
Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
|
Phase 4 | |
Completed |
NCT05391607 -
Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement
|
Phase 4 | |
Completed |
NCT03152461 -
Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
|
||
Recruiting |
NCT02441751 -
Intraoperative Volume Management and QT Interval
|
||
Completed |
NCT01053169 -
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
|
N/A |