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NCT Number: NCT00517127

Crystalloids Versus Colloids During Surgery

The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.

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Key information

Conditions

Fluid Overload Edema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

For a long time there is a raging debate whether crystalloid solutions or colloid solutions are better suited for fluid therapy. Early proponents both for crystalloids [Shires 1961] and colloids [Shoemaker 1979] deserve credit for elucidating important facts about volume replacement therapy - without answering the primary question. Elaborate reviews comparing crystalloid and colloid therapy for critically ill patients have been performed in the late nineties and updated recently [Roberts 2004]. However, it has been suggested that both questions and answers of reviews leave us none but wiser [Webb 1999]. Although a plethora of studies comparing crystalloid vs. colloid therapy in the last decades have been published, volume replacement therapy is still considered to be based on dogma and personal beliefs [Boldt 2003].

Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies volume-responders, thereby decreasing length of stay in hospital in orthopedic [Sinclair 1997], cardiac [Mythen 1995], and abdominal surgery patients [Gan 2002, Wakeling 2005, Noblett 2006]. However, all these studies have been performed with a colloid to be the substance applied. Thus, it has been questioned whether monitoring with the Esophageal Doppler monitor, or the application of additional colloid improved outcome [Horowitz, Kumar 2003].

Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on various organ systems, assessing combined perioperative morbidity [Bennett-Guerrero 1999] .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • After written informed consent patients undergoing elective open colon surgery, or open hysterectomy or myomectomy, or spine surgery or hip replacement will be included in the study.

Exclusion criteria

  • Patients having severe cardiac or renal insufficiency
  • Patients with severe coronary artery disease
  • Patients with insulin-dependent diabetes mellitus
  • Patients with severe COPD
  • Patients with symptoms of infections or sepsis
  • Patients with allergy to hydroxyethylstarch.

Treatment and study plan

Lactated Ringer's solution

Drug

Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.

Hydroxyethylstarch 6% 130/0.4

Drug

Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.

Primary outcomes

  1. combined perioperative morbidity

    Time frame: 30 days after surgery

Secondary outcomes

  1. Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,

    Time frame: 30 days after surgery

Other outcomes

  1. Coagulation (ROTEM)

    Time frame: intraop, postop day1

    in a subgroup of 50 patients undergoing hepatic resection ROTEM measurements will be performed intraoperatively, postoperatively and on the first postoperative morning and compared between the groups.

  2. Inflammatory response attenuation by HES 130/0.4

    Time frame: 4 postoperative days

    In a subgroups of 120 patients the postoperative immune function will be evaluated and compared between crystalloids and colloids.

    The immunological parameters include:

    IL6, IL-8, IL-10, Procalcitonin, lipopolysaccharide-binding protein, HLA-DR Expression, CRP C-reactive protein, leucocytes, TNF alpha Blood samples will be collected immediately before surgery (T0) for baseline measurement, immediately after surgery finish (T1), and on postoperative day one, two and four (T2, T3 and T4).

  3. Body Composition Monitor Measurement (BCM)

    Time frame: pre and postoperatively

    In a subgroup of 100 patients overhydration will be evaluated pre- and immediately postoperatively with a body composition monitor (BCM), a whole-body bioimpedance spectroscopy device manufactured and distributed by Fresenius Medical Care, Germany.

    Measurements will be compared betwwen the groups

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Fresenius Kabi

Registry information

Official study title

A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management

Acronym: CC

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Aug 16, 2007
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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