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Pulmonary EdemaNCT00995228

Fluid Management in the Post-Anesthetic Care Unit (PACU) at Sourasky Medical Center

An observational study of Pulmonary Edema and Acute Lung Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Peri-operative fluid therapy is a controversial area with few randomized trials to guide practice. Fluid management has a significant influence on outcome following surgery. Yet practically, fluid prescription practice during this period is sub-optimal, resulting in avoidable iatrogenic complications. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Edema, Acute Lung Injury, Hypertension
How many people
1,000 participants
Where
1 siteIsrael
Study dates
Mar 2009to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients from both sexes >18 y/o, undergoing elective general or orthopedic surgery

Who may be able to join

  • Men and women > 18 years old
  • ASA I-III
  • Undergoing elective general or orthopedic surgery

Who cannot join

  • Emergency procedures

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Tel Aviv Sourasky medical center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: The Practice of Fluid Management in the Post-anesthetic Care Unit (PACU) in Patients Undergoing Elective Surgery: an Observational Study

Peri-operative fluid therapy is a controversial area with few randomized trials to guide practice. Fluid management has a significant influence on outcome following surgery. Yet practically, fluid prescription practice during this period is sub-optimal, resulting in avoidable iatrogenic complications.

Several studies have assessed the effect of a 'liberal' vs. a 'restrictive' perioperative fluid regimen on post-operative outcome. However, most of these studies have focused primarily on intra-operative fluid management, whereas postoperative strategies have been less well defined, even though the immediate postoperative period is of critical importance to the patient's recovery. Moreover, whereas intra-operative fluid administration is monitored by the anesthesiologist, postoperatively it is less supervised and may result in excess or lack of intravenous (IV) fluids. Therefore, fluid management audit at the post-anesthesia care unit (PACU) is of paramount importance for patient healthcare. The objective of this study is to follow and report the current practice of fluid administration in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first step towards establishing evidence-based guidelines for postoperative fluid management.

Read the detailed description

Background

Perioperative intravenous (IV) fluid management has been a historically controversial issue in anesthesiology. Accumulating evidence suggest that regulated perioperative fluid management has beneficial effects on postoperative outcomes. A restricted perioperative IV fluid regimen aiming at unchanged body weight resulted in reduced complications after elective colorectal resection (1). In another study, patients receiving a reduced intraoperative fluid volume demonstrated less postoperative complications, lower morbidity rates and shorter hospital stay after intraabdominal surgery (2). Conversely, whereas restricted postoperative IV salt and water intake shortened gastrointestinal (GI) function and hospitalization after colonic resection in one study (3), it had no effect on the same outcomes in another randomized clinical trial (4).

Despite the reported benefits of restrictive fluid therapy, this strategy may be associated with adverse outcomes. Inadequate fluid administration can lead to a reduced effective circulating volume resulting in inefficient tissue perfusion (5-7). On the other hand, overhydration, resulting from perioperative fluid excess, has shown association with deleterious effects on cardiac and pulmonary function (8-12), and on recovery of GI motility (2,3,13), tissue oxygenation (14), wound healing and coagulation (15-16). Erroneous fluid administration is generally associated with increased morbidity and postoperative complications (17-21). Altogether, these observations call for a standardized and regulated fluid therapy throughout the perioperative period taking into account patients' premorbid diseases and type of surgery.

Previous studies have focused primarily on intra-operative fluid management. Postoperative strategies have been less well defined, even though the immediate postoperative period is of critical importance to the patient's recovery. Moreover, whereas intra-operative fluid administration is monitored by the anesthesiologist, postoperatively it is less supervised and may result in excess or lack of IV fluids.

The aim of this study is thus to follow and present the current practice of fluid administration in the PACU of Tel Aviv Sourasky Medical Center, for an extended period of time as a first step towards establishing evidence-based guidelines for postoperative fluid management.

Methods

We will collect data regarding intra- and postoperative fluid administration from the charts of >18 years old ASA I-III patients undergoing elective general or orthopedic surgery. Patients with renal/cardiac failure will be analyzed separately, since their pathology dictates extra caution with fluid therapy. Patients demographics, type of surgery, and the type and volume of fluids given during the operation and PACU stay, will be documented as well as the occurrence of morbidity in PACU, without any interventions. Data collection will be anonymous and will last six months. The setting will be the PACU of the Tal Aviv Sourasky Medical center.

Suggested benefits

The purpose of this data report is to provide an overview on the current practice of fluid management in Tel Aviv Sourasky Medical Center's PACU. We believe that this is a preliminary necessary step towards establishing guidelines for postoperative fluid management.

Study Objective

To describe the contemporary practice of postoperative fluid management in the PACU of the Sourasky Medical Center.

References

  1. Brandstrup B, Tonnesen H, Pott F et al (2003). Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg 238:641-8.
  2. Nisanevich V, Felsenstein I, Matot I, et al (2005). Effect of intraoperative fluid management on outcome after intraabdominal surgery.Anesthesiology.103:25-32.
  3. Lobo DN, Bostock KA, Allison SP, et al (2002). Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomised controlled trial. Lancet 359:1812-8.
  4. MacKay G, Fearon K, O'Dwyer PJ et al (2006). Randomized clinical trial of the effect of postoperative intravenous fluid restriction on recovery after elective colorectal surgery. Br J Surg 93:1469-74.
  5. Arkilic CF, Taguchi A, Sharma N, et al (2003). Supplemental perioperative fluid administration increases tissue oxygen pressure. Surgery 133:49-55.
  6. Bennett-Guerrero E, Welsby I, Dunn TJ, et al (1999). The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg 89:514-9.
  7. Mythen MG, Webb AR (1995). Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg 130:423-9.
  8. Arieff AI (1999). Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest 115: 1371-77.
  9. Turnage WS, Lunn JJ (1993). Postpneumonectomy pulmonary edema. A retrospective analysis of associated variables. Chest. 103:1646-50.
  10. Mathru M, Blakeman BP (1993). Don't drown the "down lung". Chest 103:1644-5.
  11. Jordan S, Mitchell JA, Quinlan GJ, Goldstraw P, Evans TW. The pathogenesis of lung injury following pulmonary resection. Eur Respir J 2000; 15: 790-9
  12. Patel RL, Townsend ER, Fountain SW (1992). Elective pneumonectomy: factors associated with morbidity and operative mortality. Ann Thorac Surg 54: 84-8
  13. Prien T, Backhaus N, Pelster F, Pircher W, Bunte H, Lawin P (1990). Effect of intraoperative fluid administration and colloid osmotic pressure on the formation of intestinal edema during gastrointestinal surgery. J Clin Anesth 2: 317-23
  14. Heughan C, Ninikoski J, Hunt TK (1972). Effect of excessive infusion of saline solution on tissue oxygen transport. Surg Gynecol Obstet 135: 257-60
  15. Janvrin SB, Davies G, Greenhalgh RM (1980). Postoperative deep vein thrombosis caused by intravenous fluids during surgery. Br J Surg. 67:690-3
  16. Hartmann M, Jönsson K, Zederfeldt B (1992). Effect of tissue perfusion and oxygenation on accumulation of collagen in healing wounds. Randomized study in patients after major abdominal operations. Eur J Surg 158:521-6.
  17. Mutoh T, Lamm WJ, Embree LJ, Hildebrandt J, Albert RK (1992). Volume infusion produces abdominal distension, lung compression, and chest wall stiffening in pigs. J Appl Physiol 72: 575-82
  18. Ratner LE, Smith GW (1993). Intraoperative fluid management. Surg Clin North Am 73: 229-41
  19. Moore FD, Shires G (1967). Moderation. Ann Surg 166:300-1.
  20. Alsous F, Khamiees M, Manthous CA, et al (2000). Negative fluid balance predicts survival in patients with septic shock: a retrospective pilot study. Chest 117: 1749-54.
  21. Callum KG, Gray AJG, Hoile RW, et al (1999) Extremes of age: the 1999 report of the national confidential enquiry into perioperative deaths. London: National Confidential Enquiry into Perioperative Deaths.
Keywords
overhydration, fluid restriction, post-anesthesia care unit
Medical subject headings
Pulmonary Edema, Acute Lung Injury, Hypertension, Renal Insufficiency, Water Intoxication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00995228
Sponsor's protocol ID
TASMC-09-IM-0501-CTIL
Status last verified
Oct 2009
First submitted
14 Oct 2009
Last updated
15 Oct 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Edema and Acute Lung Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.

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